An interventional study of Heart rate variability Biofeedback [HRV-BFB] and Pseudo HRV-BFB in Functional Neurological Disorder, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Supportive care
Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.
Although Functional Neurological Disorders (FND) represent one of the most common reasons for consultation in Neurology, the pathological mechanisms remain unexplained. Recent studies suggest disrupted emotional processes in patients with FND and disturbed autonomic nervous system profiles, highligting the hypothesis of autonomic endophenotypes among the FND population.
The Heart Rate Variability Biofeedback (HRV-BFB) is an innovative and non-invasive approach, based on the self-regulation of autonomic physiological processes. It has shown promising results in clinical and non-clinical populations but has never been assessed in an adult FND population.
Therefore, this approach appears particularly promising for understanding the mechanisms underlying FND and developing personalized therapy.
The main objective is to investigate the clinical effects of HRV-BFB on FND patients compared to placebo in a single-blind crossover design.
The investigators predict that depending on their autonomic profile, patients will respond to HRV-BFB to varying degrees.
Firstly, patients with FND will prospectively undergo an comprehensive clinical evaluation considering symptoms, functional capacity, quality of life, and an assessment of the physical and psychological comorbidities. Then patients will complete an emotional task and undergo multimodal autonomic measures. Cluster analyses will be conducted to identify both dysfunctional and functional autonomic profiles associated with the clinical exploration, enabling confirmation of the endophenotypes hypothesis and allowing for specific characterization of the profils. The clinical evaluation of the beneficial effects of HRV BFB will rely on repeated mesures of symptoms, functional capacity, and quality of life at scheduled points in time before and after the both interventions (HRV-BFB and pseudo-BFB). The emotional task and autonomic measures will be repeated simultaneously.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 31 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.
Other: Heart rate variability Biofeedback [HRV-BFB]
Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.
Other: Pseudo HRV-BFB
Biofeedback (BFB), sometimes referred to as "biological feedback technique," is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population.
The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.
Patient Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Day 1 (V1)
Patient Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 40 days from V1 (V2)
Patient Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 80 days from V1 (V3)
Patient Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 180 days from V1 (V4)
Patient Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the participant using the Clinical Global Impression Improvement and/or Severity scale ( (CGI-I \& CGI-S; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 360 days from V1 (V5)
Clinician Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Day 1 (V1)
Clinician Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 40 days from V1 (V2)
Clinician Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 80 days from V1 (V3)
Clinician Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 180 days from V1 (V4)
Clinician Clinical Global Impression Score
The impression improvement and severity of the core symptoms will be measured by the clinician using the Clinical Global Impression Improvement and/or Severity scale (CGI; French version Busner \& Targum, 2007). This scale includes 2 items.
Time frame: Up to 360 days from V1 (V5)
Quality of life Score
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Time frame: Day 1 (V1)
Quality of life Score
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Time frame: Up to 40 days from V1 (V2)
Quality of life Score
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Time frame: Up to 80 days from V1 (V3)
Quality of life Score
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Time frame: Up to 180 days from V1 (V4)
Quality of life Score
The Quality of life Score will be measured using the 36-Item Short Form Survey (SF-36; Jenkinson et al., 1993; French version Leplège et al., 1998). This scale includes 36 items.
Time frame: Up to 360 days from V1 (V5)
Self-perception of Occupation Score
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
Time frame: Day 1 (V1)
Self-perception of Occupation Score
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
Time frame: Up to 40 days from V1 (V2)
Self-perception of Occupation Score
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
Time frame: Up to 80 days from V1 (V3)
Self-perception of Occupation Score
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
Time frame: Up to 180 days from V1 (V4)
Self-perception of Occupation Score
The Self-perception of Occupation will be measured using the Occupational Self- Assessment scale (OSA; French version Baron et al.,2006). This scale includes 21 items.
Time frame: Up to 360 days from V1 (V5)
Other physical symptoms score
The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.
Time frame: Day 1 (V1)
Other physical symptoms score
The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.
Time frame: Up to 40 days from V1 (V2)
Other physical symptoms score
The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.
Time frame: Up to 80 days from V1 (V3)
Other physical symptoms score
The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.
Time frame: Up to 180 days from V1 (V4)
Other physical symptoms score
The other physical symptoms will be measured using the Patient Health Questionnaire (PHQ-15; French version Kroenke et al., 2002). This scale includes 15 items.
Time frame: Up to 360 days from V1 (V5)
Depressive symptoms score
The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items.
Time frame: Day 1 (V1)
Depressive symptoms score
The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items.
Time frame: Up to 40 days from V1 (V2)
Depressive symptoms score
The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items.
Time frame: Up to 80 days from V1 (V3)
Depressive symptoms score
The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items.
Time frame: Up to 180 days from V1 (V4)
Depressive symptoms score
The Depressive symptoms score will be measured using the for Epidemiologic Studies-- Depression (CES-D; Radloff, 1977; French version Führer \& Rouillon, 1989). This scale includes 20 items.
Time frame: Up to 360 days from V1 (V5)
Trait anxiety score
The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.
Time frame: Day 1 (V1)
Trait anxiety score
The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.
Time frame: Up to 40 days from V1 (V2)
Trait anxiety score
The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.
Time frame: Up to 80 days from V1 (V3)
Trait anxiety score
The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.
Time frame: Up to 180 days from V1 (V4)
Trait anxiety score
The Trait anxiety score will be measured using the Trait Anxiety Inventory (STAI- B; Spielberger, 1989; French version Bruchon-Schweitzer \& Paulhan, 1993; Huyghe Lydie, 2021). This scale includes 20 items.
Time frame: Up to 360 days from V1 (V5)
Quality of sleep measure
The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.
Time frame: Day 1 (V1)
Quality of sleep measure
The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.
Time frame: Up to 40 days from V1 (V2)
Quality of sleep measure
The quality of sleep measure will be measure using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.
Time frame: Up to 80 days from V1 (V3)
Quality of sleep measure
The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.
Time frame: Up to 180 days from V1 (V4)
Quality of sleep measure
The quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2002, French versionAit-Aoudia et al., 2013). This scale includes 7 items.
Time frame: Up to 360 days from V1 (V5)
Dissociative Experiences
The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.
Time frame: Day 1 (V1)
Dissociative Experiences
The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.
Time frame: Up to 40 days from V1 (V2)
Dissociative Experiences
The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.
Time frame: Up to 80 days from V1 (V3)
Dissociative Experiences
The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.
Time frame: Up to 180 days from V1 (V4)
Dissociative Experiences
The Dissociative Experiences will be measured using the Dissociative Experiences Scale EDS; Steinberg et al., 1991; french version Eve Bernstein Carlson et Frank W. Putnam, 1986). This scale includes 28 items.
Time frame: Up to 360 days from V1 (V5)
Alexithymia score
Alexithymia score will be measured using the Toronto Alexithymia Scale (TAS-20; French version Loas, 1996). This scale includes 20 items.
Time frame: Day 1 (V1)
Brief Illness Perception score
Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.
Time frame: Day 1 (V1)
Brief Illness Perception score
Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.
Time frame: Up to 40 days from V1 (V2)
Brief Illness Perception score
Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.
Time frame: Up to 80 days from V1 (V3)
Brief Illness Perception score
Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.
Time frame: Up to 180 days from V1 (V4)
Brief Illness Perception score
Brief Illness Perception score will be measured using the Brief Illness Perception Questionnaire (B-IPQ) (Moss-Morris et al., 2002 ; French version Demoulin et al., 2015). This scale includes 9 items.
Time frame: Up to 360 days from V1 (V5)
Emotion Regulation Profile
The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.
Time frame: Day 1 (V1)
Emotion Regulation Profile
The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.
Time frame: Up to 40 days from V1 (V2)
Emotion Regulation Profile
The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.
Time frame: Up to 80 days from V1 (V3)
Emotion Regulation Profile
The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.
Time frame: Up to 180 days from V1 (V4)
Emotion Regulation Profile
The Emotion Regulation Profile score will be measured using the Emotion Regulation Profile-Revised (ERP-R) (French version Nelis et al., 2011). This scale includes 15 items.
Time frame: Up to 360 days from V1 (V5)
Childhood Trauma profile
The Childhood Trauma profile will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Frenc version Paquette et al., 2004). This scale includes 28 items.
Time frame: Day 1 (V1)
Positive Affect and Negative Affects
The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.
Time frame: Day 1 (V1) before the emotional induction task
Positive Affect and Negative Affects
The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.
Time frame: Day 1 (V1) after the emotional induction task
Positive Affect and Negative Affects
The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.
Time frame: Up to 40 days from V1 (V2) before the emotional re-exposure task
Positive Affect and Negative Affects
The Positive Affect and Negative Affects will be measured using the Positive Affect and Negative Affect Schedule (PANAS; Watson et al., 1988. French version Caci \& Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. This scale includes 20 items.
Time frame: Up to 40 days from V1 (V2) after the emotional re-exposure task
High Frequency [HF] (>0.15 Hz)
High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Day 1 (V1)
High Frequency [HF] (>0.15 Hz)
High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 40 days from V1 (V2)
High Frequency [HF] (>0.15 Hz)
High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 80 days from V1 (V3)
High Frequency [HF] (>0.15 Hz)
High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 180 days from V1 (V4)
High Frequency [HF] (>0.15 Hz)
High Frequency (\>0.15 Hz), frequency-domain parameter. HF will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 360 days from V1 (V5)
Root Mean Square of Successive Differences [RMSSD]
Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Day 1 (V1)
Root Mean Square of Successive Differences [RMSSD]
Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 40 days from V1 (V2)
Root Mean Square of Successive Differences [RMSSD]
Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 80 days from V1 (V3)
Root Mean Square of Successive Differences [RMSSD]
Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 180 days from V1 (V4)
Root Mean Square of Successive Differences [RMSSD]
Root Mean Square of Successive Differences, Frequency-domain parameter. RMSSD will be measured using the electrocardiogram \[ECG\]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability \[HRV\].
Time frame: Up to 360 days from V1 (V5)
Skin conductance responses [SCR] frequency
Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Day 1 (V1)
Skin conductance responses [SCR] frequency
Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 40 days from V1 (V2)
Skin conductance responses [SCR] frequency
Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 80 days from V1 (V3)
Skin conductance responses [SCR] frequency
Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 180 days from V1 (V4)
Skin conductance responses [SCR] frequency
Skin conductance responses \[SCR\] frequency : number of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 360 days from V1 (V5)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Day 1 (V1)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 40 days from V1 (V2)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 80 days from V1 (V3)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 180 days from V1 (V4)
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods. SCR will be measured using the Galvanic skin responses \[GSR\]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time frame: Up to 360 days from V1 (V5)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Day 1 (V1)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 40 days from V1 (V2)
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 80 days from V1 (V3)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Day 1 (V1)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 40 days from V1 (V2)
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 80 days from V1 (V3)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Day 1 (V1)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 40 days from V1 (V2)
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 80 days from V1 (V3)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Day 1 (V1)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 40 days from V1 (V2)
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 80 days from V1 (V3)
Gamma frequency (>30Hz)
Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Day 1 (V1)
Gamma frequency (>30Hz)
Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 40 days from V1 (V2)
Gamma frequency (>30Hz)
Gamma frequency \>30 Hertz band Gamma frequency will be measured using the electroencephalogram \[EEG\]: EEG data will be recorded using a EEG headsets including 128 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time frame: Up to 80 days from V1 (V3)
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for May 2027, 32 months after the start.
Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM) →