Impulsivity With Borderline Personality Disorder/tMS

NCT05942651 | Recruiting DMC

• 1 other identifier: 2023-A00772-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; brain stimulation; impulsivity

Outcome Measures

Primary Outcomes (1)

• Significant reduction in reaction time of the Emotional Stop Signal (SSRT) for the ccPAS4-ms group compared to the ccPAS100-ms sham group

  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

  2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups

Secondary Outcomes (4)

• 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

  2 times: Outcome measure will be assessed: immediately before the ccPAS protocol and immediately after the ccPAS protocol, for both groups

• Levels of intracortical inhibition within M1.

  1 time: Measured before the ccPAS protocol, in both groups.

• Duration of cortical silence period (in ms).

  1 time: Measured before the ccPAS protocol, in both groups

• Cognitive task manipulating environment-emotion-behavior interactions.

  1 time: Measured before the ccPAS protocol, in both groups.

Study Arms (2)

active ccPAS4-ms

ACTIVE COMPARATOR

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

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

Control condition ccPAS100-ms.

SHAM COMPARATOR

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

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

Interventions

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

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

active ccPAS4-ms

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

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

Control condition ccPAS100-ms.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, AURA, 69678 CEDEX, France

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder; Impulsive Behavior

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavior

Central Study Contacts

POULET Emmanuel, PUPH

CONTACT

0437915565; emmanuel.poulet@chu-lyon.fr

sartelet lydie

CONTACT

lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be block randomized (1:1) to receive either active ccPAS4-ms or sham ccPAS100-ms. Computer generated random numbers will be used to generate the allocation sequence. The allocation sequence will be handled by an independent person from the Administrative Department of the Hospital and will be unavailable to those who enroll and assign patients. Patients will be blind to their treatment assignment. Moreover, the medical doctors who will administer the clinical scales and the researchers that will analyze the data will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, double-blind, parallel-group controlled trial with two arms.

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2027
• Last Updated: March 7, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)