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

February 11, 2023 updated by: Ahmad Al Zatam, Ciusss de L'Est de l'Île de Montréal

Effects of Transcranial Direct Current Stimulation in Conjugation With Psychotherapy on Impulsivity in Patients With Borderline Personality Disorder

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1N 3M5
        • Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of NIBS on impulsivity (UPPS- Behavioral Impulsive scale)
Time Frame: 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.
2-week stimulation session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI)
Time Frame: 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)
3 months
The Effect of tDCS on Risk taking ( an impulsive behavior dimension)
Time Frame: 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
2 weeks
the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS))
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2021

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ACTUAL)

July 20, 2022

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (ACTUAL)

July 12, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are planning to share the results only while keeping the coincidentally for the participants

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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