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The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder

Sponsor
Ciusss de L'Est de l'Île de Montréal (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05453032
Collaborator
Dr. Lionel Cailhol, checf of psychiatry department at Montreal Psychiatric Institute (IUSMM) (Other)
13
Enrollment
1
Location
1
Arm
14.3
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A pilot study to examine the effects of Non-Invasive Brain stimulation on impulsive behaviour in patients diagnosed with Borderline Personality Disorder. patients who received the neurostimulation sessions will be enrolled in short term psychotherapy (3-month)

Condition or Disease Intervention/Treatment Phase
  • Device: NeuroConn
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
we recruited 10 patients who attended a 10-session of tDCS stimulation. Each session lasted for 20 minutes in a 2-week.we recruited 10 patients who attended a 10-session of tDCS stimulation. Each session lasted for 20 minutes in a 2-week.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Transcranial Direct Current Stimulation in Conjugation With Psychotherapy on Impulsivity in Patients With Borderline Personality Disorder
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy

Patients diagnosed with Borderline Personality disorder and BPDSI score is > or = 17 will be assigned for active tDCS session (NeuroConn, Germany) candidates will have 20-minute session per day for 10 weekdays in 2 weeks. Then they will attend short term psychotherapy session for 3 months.

Device: NeuroConn
A neurostimulation decivse that works be generating weak electric current via Electrodes. These electrodes placed on a specific cerebral location, where the defect assumed to be there) to modulate the neuronal activity. This neuronal modulation does not induce or fire action potential but it facilitate action potentials and cerebral interconnection as well corticolimbic connection)
Other Names:
  • tDCS
  • transcranial Direct Current Stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effect of NIBS on impulsivity (UPPS- Behavioral Impulsive scale) [2-week stimulation session]

      Patients with BPD will complete UPPS impulsive behavioral scale, a self reported questionnaire, before the first tDCS session and after they complete the 10 sessions of tDCS sessions. this questionnaire consists of 45 questions with 4 likert scale range for each question. The questionnaire is divided into 4 subscales: Urgency, lack of premeditation, lack of perseverance, sensation seeking.

    Secondary Outcome Measures

    1. The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI) [3 months]

      The BPD patients who attend the tDCS sessions and the short-term psychotherapy will be evaluated by one psychiatric with a semi-structured interview evaluation, Borderline Personality disorder Severity Index (BPDSI)

    2. The Effect of tDCS on Risk taking ( an impulsive behavior dimension) [2 weeks]

      a computerized measure of risk taking behavior. Each participant will have a set of 30 balloons with temporary and permanent bank. The possibility of balloon explosion increased each time the participant inflate ( click on the balloon) while the amount of money increased by 0.5 euro with each inflation. the participant could more the earned money from inflation anytime before unexpected balloon explosion to the permanent bank. The total number of the pumps will determine the probability of risk taking behavior

    3. the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS)) [2 weeks]

      A self reported questionnaire that assess the depressive symptoms in the last 3 days. it consists of 9 questions with 3 likert score range ; each question examines different aspect of depression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Clinical Diagnosis of Borderline Personality Disorder (DSM-V)

    • Resident of Great Montreal

    • Ability to make decision

    • Clinical score is equal or more than 17 in Borderline Personality Disorder Severity Index (BPDSI)

    resident of greater Montreal Area,

    Exclusion Criteria:

    • material Metal in the brain

    • History of seizure or epilepsy

    • severe scalp irritation or eczema

    • recent scares, cut wounds, tattoo on the scalp

    • severe substance use disorder

    • clinical diagnosis of severe mood disorders o

    • Active psychotic episode

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal Montréal Quebec Canada H1N 3M5

    Sponsors and Collaborators

    • Ciusss de L'Est de l'Île de Montréal
    • Dr. Lionel Cailhol, checf of psychiatry department at Montreal Psychiatric Institute (IUSMM)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmad Al Zatam, Master's Student, Ciusss de L'Est de l'Île de Montréal
    ClinicalTrials.gov Identifier:
    NCT05453032
    Other Study ID Numbers:
    • 2021-2308
    First Posted:
    Jul 12, 2022
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ahmad Al Zatam, Master's Student, Ciusss de L'Est de l'Île de Montréal
    impulsivity
    Non-Invasive Brain Stimulation
    Psychotherapy
    Additional relevant MeSH terms:
    Personality Disorders
    Borderline Personality Disorder
    Impulsive Behavior

    Study Results

    No Results Posted as of Jul 12, 2022