Clinical trial NCT05942651: Impulsivity With Borderline Personality Disorder/tMS
Official title: Reduction of Impulsivity in Patients With Borderline Personality Disorder Using Dual-site Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
brain stimulation
impulsivity
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, double-blind, parallel-group controlled trial with two arms.
Primary purpose: TREATMENT

Brief 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)).

Eligibility criteria: 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 outcomes:
measure: Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group
timeFrame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
Secondary outcomes:
measure: 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
timeFrame: 2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups
measure: Levels of intracortical inhibition within M1.
timeFrame: 1 time: Measured before the ccPAS protocol, in both groups.
measure: Duration of cortical silence period (in ms).
timeFrame: 1 time: Measured before the ccPAS protocol, in both groups
measure: Cognitive task manipulating environment-emotion-behavior interactions.
timeFrame: 1 time: Measured before the ccPAS protocol, in both groups.
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Aura
Study officials:
References: