NCT05942651

Impulsivity With Borderline Personality Disorder/tMS

Reduction of Impulsivity in Patients With Borderline Personality Disorder Using Dual-site Transcranial Magnetic Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)).

Conditions

• Borderline Personality Disorder

Interventions

Type	Name	Description
DEVICE	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
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 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

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-09-20
• Completion: 2027-09-20
• First posted: 2023-07-12
• Last updated: 2024-03-07

Locations

1 site across 1 country: France