Impulsivity With Borderline Personality Disorder/tMS (IMPULSE)

Hôpital le Vinatier

Status: Enrolling

Conditions: Borderline Personality Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05942651

2023-A00772-43

Details and patient eligibility

About

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.

Full 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)).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

active ccPAS4-ms

Active Comparator group

Description:

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

Treatment:

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

Control condition ccPAS100-ms.

Sham Comparator group

Description:

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

Treatment:

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