An interventional study of Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals. and Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals in Borderline Personality Disorder, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham.
Borderline personality disorder (BPD) is a mental disorder characterized by unstable interpersonal relationships, emotional lability and marked impulsivity. The latter manifests itself through risky behaviors such as substance abuse, self-harm and suicidal behavior.
Studies suggest that 1.3% of the general population suffers from BPD. However, in clinical settings, BPD patients represent 20% of all inpatients in psychiatric wards and up to 50% of patients hospitalized in emergency departments following a suicide attempt (SA). Moreover, it is estimated that nearly 84% of BPD patients will make at least one SA in their lifetime and up to 10% of them will die by suicide, a rate 50 times higher than the general population. Impulsivity, reflected in difficulties holding back action or stopping an action that has already begun, is one of the key symptoms of BPD.
Recent advances in non-invasive brain stimulation have led to the emergence of a new stimulation protocol known as Paired Cortico-Cortical Associative Stimulation (ccPAS), which consists of repeating paired stimulations using two TMS coils placed respectively on two cortical regions of interest. Paired stimulations' repetition induces plasticity by strengthening synaptic connectivity between the two targeted regions.
The aim of this project is to test the efficacy of a ccPAS protocol in enhancing effective connectivity between the IFC and pre-SMA in order to reduce impulsivity in BPD patients.
The Sponsor hypothesized that one ccPAS session, using two coils simultaneously, targeting the IFC and pre-SMA with a 'physiological' inter-stimulus interval of 4ms will improve motor inhibition abilities (reduce SSRT), compared to the group receiving 'control' ccPAS (100ms inter-stimulus interval (ccPAS100-ms)).
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
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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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I). Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline. The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals.
Device: Magstim BiStim 2002 (The Magstim Company Ltd., Spring Gardens, Whitland, UK) and two small coils (40mm, figure-of-eight coils, Alpha B.I). Coil 1 was positioned over right IFC at a 20° angle to the coronal plane with the handle pointing anteriorly, and coil 2 was positioned over right pre- SMA perpendicular to the midline. The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
Device: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 4 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
The first stimulation will be applied to the IFC and the second to the pre-SMA, with an interstimulation interval set at 100 ms. A total of 180 stimulation pairs will be delivered every 2 s. (5Hz) for a total duration of 15 minutes at an intensity of 120% of rMT
Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group
The ability to inhibit an action (motor inhibition) is quantified using a 'Stop Signal' task in which the reaction time required to inhibit the action (SSRT) is calculated. The longer the SSRT, the poorer the ability to inhibit an action and the greater the motor impulsivity
Time frame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Increased effective inhibitory connectivity within the fronto-striatal network (DLPFC-M1), intracortical inhibition (short and long interval) and cortical silent period for the ccPAS4-ms group, when compared with the ccPAS100-ms group
Dual-site transcranial magnetic stimulation (TMS) can be used to probe effective connectivity between the left DLPFC and the left M1 (Wang et al. 2021). Conditioned motor evoked potential (MEP) amplitude evoked by dual-site TMS and measured with surface electromyography (EMG) is compared to MEP amplitude evoked by TMS applied over M1 alone.
Time frame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Levels of intracortical inhibition within M1.
Paired-pulse TMS provides a non-invasive method to study intracortical inhibitory circuits. Short-interval intracortical inhibition (SICI) is a well-established paired-pulse measure of inhibitory circuitry within the M1 area. SICI results from a subthreshold conditioning stimulus (CS) followed 3.5 ms later by a suprathreshold test stimulus (TS) delivered through the same coil over M1. This measurement will be correlated with the other inhibition measurements (SSRT at baseline and duration of the silent period) to provide an overall view of the efficacy/inefficacy of this inhibitory system in patients with borderline personality disorder.
Time frame: 1 time: Measured before the ccPAS protocol, in both groups.
Duration of cortical silence period (in ms).
Single-pulse TMS applied over M1 during a voluntary contraction elicited a motor evoked potential followed immediately by a period of EMG silence that has been assumed to reflect intracortical inhibition. This measurement will be correlated with the other inhibition measurements (SSRT at baseline and SICI) to provide an overall view of the efficacy/inefficacy of this inhibitory system in patients with borderline personality disorder.
Time frame: 1 time: Measured before the ccPAS protocol, in both groups
Cognitive task manipulating environment-emotion-behavior interactions.
The task is framed to participants as being a fish gathering algae while predators might approach for which they need to check and if appropriate hide. The task features differentially evoke emotions of stress and excitement. Self-reported stress and threat-avoidance behaviors during the task will be measured.
Time frame: 1 time: Measured before the ccPAS protocol, in both groups.
Plan to share: No
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Started Jan 2024 (actual). Primary completion is estimated for Sep 2026, 32 months after the start.
Of 105 non-industry interventional studies with no phase under Borderline Personality Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's planned 32 months is close to that.
Counting every sponsor, half of 107 studies reached it within 35 months; a quarter within 24 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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