An interventional study of Mindfulness-based stress reduction therapy and Inhibitory TMS in Functional Neurological Symptom Disorder and Neurological Diseases or Conditions, sponsored by University of Fribourg. Completed at 1 site in Switzerland. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by University of Fribourg · Not applicable, Interventional, and Treatment
A conversion disorder is a dysfunction of the nervous system in which no structural damage can be demonstrated. However, it must be distinguished from other psychiatric disorders such as psychosis or depression. There are a variety of signs of the disease, such as muscle paralysis, uncontrolled tremors or cramps. In rarer cases, blindness, deafness or numbness may occur. Diagnosing this complex disorder has always been a challenge for neurologists and psychiatrists.
This study investigates the effects of transcranial magnetic stimulation (TMS) on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects. The TMS method allows to target specific areas of the brain by means of magnetic fields. This technique is not painful and does not have long-lasting effects.
In addition, the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects. This technique is not painful and has no long-lasting effects.
Furthermore, the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality.
Finally, the study examines patients' brain activity while playing a game targeting the sense of agency in real time, which is recorded with an MRI scanner.
The study includes a maximum of twelve sessions in total (ten sessions of approximately 1.5-2 hours each and two sessions each overnight). The planned study methods include TMS, (real-time and normal) magnetic resonance tomography of the brain (MRI "tube"), virtual- and augmented reality (AR/VR), questionnaires, blood, saliva, and motion sensors (e.g., fitness bracelet), and participation in the 8-week mindfulness program.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's enrollment of 190 is above the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →University of Fribourg is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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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.
Patients:
healthy controls:
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of patients with functional neurological disorders
Behavioral: Mindfulness-based stress reduction therapy · Device: Inhibitory TMS · Device: TMS sham · Device: Excitatory TMS · Device: Virtual Reality · Behavioral: Neurofeedback
Group of patients with organic neurological disorders
Device: Inhibitory TMS · Device: TMS sham · Device: Excitatory TMS
Group of healthy controls
Device: Inhibitory TMS · Device: TMS sham · Device: Excitatory TMS · Device: Virtual Reality
Group of patients with functional neurological disorders
Device: Inhibitory TMS · Behavioral: Psychoeducation · Device: TMS sham · Device: Excitatory TMS · Behavioral: Neurofeedback
MBSR Therapy is a structured 8-week program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic and psychiatric disorders. The program is based upon a systematic procedure to develop enhanced awareness of moment-to-moment experience of perceptible mental processes.
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
Participants will learn about the symptoms and how to cope with the symptoms
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
The device will be used to manipulate the perception of symptoms of patients while they are playing a game in virtual/augmented reality.
Neurofeedback training will be applied in patients while laying in an MRI scanner. Patients will play a game, which targets the sense of agency, and will receive a real-time feedback about their performance and brain activity. They will learn to self-regulate their performance on the game in order to increase brain activity relevant for the sense of agency.
Change in objective Performance Agency Task (TMS)
The changes in objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the Magnetic Resonance Imaging (MRI) scanner, on a computer or in Virtual Reality before and after brain stimulation (transcranial magnetic stimulation, TMS). The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game \[-\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 7 to 11 (12 - 16 weeks)
Change in subjective Performance Agency Task (TMS)
The changes in objective and subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after brain stimulation. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 7 to 11 (12 - 16 weeks)
Change in objective Performance Agency Task (MBSR)
The objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the MRI scanner, on a computer or in Virtual Reality before and after a therapeutic intervention (mindfulness-based stress reduction, MBSR).The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game \[-\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4), visit 7 to 11 (12 - 16 weeks)
Change in subjective Performance Agency Task (MBSR)
The subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after a therapeutic intervention (MBSR). Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4), visit 7 to 11 (12 - 16 weeks)
task-based fMRI measures TMS
The functional magnetic resonance imaging (fMRI) measures of blood oxygenation signal (BOLD) in the whole brain during the behavioural task before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in intensity between conditions with conditions being before and after rTMS \[-\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline)
resting-state fMRI measures TMS
The fMRI measures of blood oxygenation in the whole brain at rest, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in functional connectivity between conditions with conditions being before and after rTMS. Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions \[-\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline)
DTI measures TMS
The fMRI measures of blood oxygenation in the whole brain using diffusion tensor imaging (DTI), before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient \[mm2/s\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline)
task-based fMRI measures MBSR
The fMRI measures of blood oxygenation in the whole brain during the behavioural task, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). BOLD is measured in change in intensity between conditions with conditions being before and after rTMS \[-\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
resting-state fMRI measures MBSR
The fMRI measures of blood oxygenation in the whole brain at rest before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). BOLD is measured in change in functional connectivity between conditions with conditions being before and after rTMS. Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions \[-\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
DTI measures MBSR
The fMRI measures of blood oxygenation in the whole brain during DTI, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient \[mm2/s\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Subjective Agency TMS
Subjective assessment of own agency during a behavioural task, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline)
Subjective Agency MBSR
Subjective assessment of own agency during a behavioural task, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Neurological Examination TMS
The performance on an objective neurological examination, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs \& A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND).
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline)
Neurological Examination MBSR
The performance on an objective neurological examination, before and after MBSR or psychoeducation in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs \& A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND).
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Objective stress parameters pre/post
The stress parameters assessed using salivary cortisol before and after MBSR Therapy compared to psychoeducation, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Cortisol levels are measured using Enzyme-linked Immunosorbent Assay (ELISA) \[ng/ul\].
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Subjective stress parameters pre/post
Subjective stress before and after MBSR Therapy compared to psychoeducation, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Subjective stress is measured using a VAS from 0-100.
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Sleep
The outcomes of ambient sensors (i.e., actigraphs) monitor non-invasively everyday life activity (ELA), including sleep, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Actigraphs measure light input and motion. A variety of outcome measures can be calculated such as Time in Bed, Time asleep,
Time frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4)
Neurofeedback
The real-time measures of blood oxygenation in the target areas (e.g., TPJ) in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. Participants will receive direct feedback on their performance in the scanner.
Time frame: Visit 7 to 11 (12 - 16 weeks)
Long-term effects on task-based fMRI measures MBSR
To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain during the behavioural task, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in intensity between conditions with conditions being at follow-up compared to Visit 5 (after MBSR therapy)\[-\].
Time frame: At follow-up (6 month after visit 5)
Long-term effects on resting-state fMRI measures MBSR
To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain at rest, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in functional connectivity between conditions with conditions being at follow-up compared to Visit 5 (after MBSR therapy). Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions \[-\]. .
Time frame: At follow-up (6 month after visit 5)
Long-term effects on DTI measures MBSR
To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain during DTI, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient \[mm2/s\].
Time frame: At follow-up (6 month after visit 5)
Long-term effects on subjective agency MBSR
To measure the long-term (six months) effect of MBSR therapy, the subjective performance on the behavioural tasks targeting the sense of agency is used. Participants rate their agency on a visual analog scale (VAS) from 0 to 10 \[-\]. Subjective agency at follow-up will be compared to subjective agency at Visit 5 (after MBSR).
Time frame: At follow-up (6 month after visit 5)
Long-term effects on neurological examination MBSR
To measure the long-term (six months) effect of MBSR therapy, the performance on an objective neurological examination will be assessed, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs \& A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND). Outcome of neurological assessment at follow-up will be compared to outcome of neurological assessment at Visit 5 (after MBSR).
Time frame: At follow-up (6 month after visit 5)
Long-term effects on objective performance
To measure the long-term (six months) effect of MBSR therapy, the objective performance on the behavioural tasks targeting the sense of agency is used. The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game \[-\]. Objective performance at follow-up will be compared to objective performance at Visit 5 (after MBSR).
Time frame: At follow-up (6 month after visit 5)
Long-term effects on subjective performance
To measure the long-term (six months) effect of MBSR therapy, the subjective performance on the behavioural tasks targeting the sense of agency is used. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 \[-\]. Objective performance at follow-up will be compared to objective performance at Visit 5 (after MBSR).
Time frame: At follow-up (6 month after visit 5)
Neurophysiological measures: MEP
Motor evoked potential (MEP) is measured by eliciting an action potential using non-invasive brain stimulation (TMS) over the motor cortex through the scalp \[% TMS - max. intensity output\]. Neurophysiological measures will be used to characterise movement disorders. We will compare MEPs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Neurophysiological measures: MT
Motor threshold (MT) measures the intensity of a pulse which elicits a predefined MEP. Neurophysiological measures will be used to characterise movement disorders. We will compare MTs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Neurophysiological measures: SICI
Short IntraCortical Inhibition (SICI) measures the reduction of the MEP occurring after weak (subthreshold) conditioning pulse followed by a supra-threshold test pulse at short interstimulus intervals (approximately 2 msec). Neurophysiological measures will be used to characterise movement disorders. We will compare SICIs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Neurophysiological measures: LICI
Long IntraCortical Inhibition (LICI) measures the reduction of MEP, as described in Outcome 28, at long interstimulus intervals (between 50 and 200 msec), using supra-threshold paired stimulation. Neurophysiological measures will be used to characterise movement disorders. We will compare LICIs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Neurophysiological measures CSP
Cortical Silent Period (CSP) measures the period of electromyography (EMG) silence before activity resumes baseline, following the MEP elicited by a pulse to the motor cortex during tonic contraction of a target muscle. Neurophysiological measures will be used to characterise movement disorders. We will compare CSPs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Neurophysiological measures: PAS
Paired Associative Stimulation (PAS) measures the increase in the MEP amplitude following lowfrequency stimulation over the median nerve of the hand, paired with TMS over the motor cortex. This is an index for plasticity. Neurophysiological measures will be used to characterise movement disorders. We will compare CSPs in patients with a functional, or organic condition, to healthy subjects.
Time frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5)
Epigenetic profile
Mean methylation rates of genes involved in the stress-pathway (i.e., Oxytocin, Serotonine, Dopamine, Glucocorticoid receptor) will be assessed in patients affected by a functional or organic disorder and healthy subjects using blood samples. Methylation profiles will be determined using the bisulfite - treatment method.
Time frame: 1st visit (baseline)
Long-term fluctuations of objective stress parameters
To assess the long-term (six months) fluctuations of stress, salivary cortisol will be measured at follow-up in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Cortisol levels are measured using Enzyme-linked Immunosorbent Assay (ELISA) \[ng/ul\].
Time frame: at follow-up (6 month after visit 5)
Long-term fluctuations of subjective stress parameters
To assess the long-term (six months) fluctuations of stress, subjective stress levels will be measured at follow-up in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Subjective stress is measured using a VAS from 0-100.
Time frame: at follow-up (6 month after visit 5)
Position of focus of attention
To assess the position of focus of attention we will use eye tracking while participants play a game in virtual reality. We assess where participants focus their attention while moving their limbs
Time frame: at visit 6 (at least one week after visit 5)
Kinematics of limb movements
To assess the kinematics of movements of participants, we apply motion tracking systems with which we measure movement translation and rotation in space.
Time frame: at visit 6 (at least one week after visit 5)
Stability
The objective and subjective sway in functional patients, organic control patients and healthy subjects will be assessed using posturography, which includes diverse balance exercises on a force plate (e.g. with eyes open / with eyes closed).
Time frame: Visit 1 (at baseline), and follow up (8 month after visit 1)
Cognition
Outcomes of neuropsychiatric test battery will be compared in functional patients, organic control patients and healthy subjects (e.g. attention, working memory), and further correlated with the fMRI BOLD signal in e.g., the multimodal vestibular network.
Time frame: Visit 1 (at baseline), and follow up (8 month after visit 1)
Pain processing
Pain processing and perception of pain will be studied in functional patients, organic patients and healthy subjects by using a standardized tool (i.e. Algopeg). Scores from Algopeg will be associated with neural correlates (e.g., resting state fMRI).
Time frame: Visit 1 (at baseline), and follow up (8 month after visit 1)
Plan to share: No
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Ran from Dec 2021 to primary completion in Dec 2024, 36 months.
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 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Fribourg