Impulsivity With Borderline Personality Disorder/tMS

Last updated: March 6, 2024
Sponsor: Hôpital le Vinatier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Borderline Personality Disorder

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

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.

Clinical Study ID

NCT05942651
2023-A00772-43
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of BPD (established by a psychiatrist and confirmed in a structuredinterview using the MINI) based on the Diagnostic and Statistical Manual of MentalDisorders (DSM V).

Exclusion

Exclusion Criteria:

  • Contraindications to TMS/MRI (pacemakers or other devices likely to interfere with themagnetic field).
  • Pregnant or breast-feeding women.
  • Ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment oranticonvulsants acting on GABAergic transmission ; 24 hours prior to the protocol.
  • Diagnosis of other chronic psychiatric pathology including bipolar disorder type I orII and addictions (except tobacco).
  • Protective measure (curatorship or guardianship)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Non-invasive brain stimulation protocol (Cortico-cortical paired associative stimulation protocol (ccPAS)) delivered at 100 ms intervals
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
September 20, 2027

Study Description

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)).

Connect with a study center

  • Centre Hospitalier Le Vinatier

    Bron, Aura 69678 CEDEX
    France

    Active - Recruiting

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