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Clinical Trials in France / NCT05942651
Recruiting Not applicable

Impulsivity With Borderline Personality Disorder/tMS

NCT05942651 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital le Vinatier
Phase
Not applicable
Started
2024-01-08
Last updated
2024-03-07

Condition(s) studied

Borderline Personality Disorder

Investigational drug(s) / intervention(s)

Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 ms intervals.Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals

Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 4 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

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 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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of BPD (established by a psychiatrist and confirmed in a structured interview using the MINI) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V). Exclusion Criteria: * Contraindications to TMS/MRI (pacemakers or other devices likely to interfere with the magnetic field). * Pregnant or breast-feeding women. * Ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment or anticonvulsants acting on GABAergic transmission ; 24 hours prior to the protocol. * Diagnosis of other chronic psychiatric pathology including bipolar disorder type I or II and addictions (except tobacco). * Protective measure (curatorship or guardianship)

Primary outcome measure(s)

  • Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group — 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
    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

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Le Vinatier Bron AURA Recruiting

More Hôpital le Vinatier trials in France

REALITY MONITORING AND DOPAMINE Recruiting
Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD Recruiting
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Evaluation of the Safety Plan to Prevent Suicidal Reiteration Recruiting
Motor Imagery in Aphantasia Recruiting

Other trials for the same condition

Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder Active, not recruiting
SHame prOpensity in bOrderline Personality Disorder Recruiting
Disorders of the Sense of Self and Physical Activity Recruiting
Evaluation of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) for the Treatment of Borderline Personality Disorder Recruiting
COMpassion for Psychiatric Disorders And Self-Stigma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05942651 on ClinicalTrials.gov ↗ ← All trials in France