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Completed

NCT Number: NCT05453032

The Effect of Non Invasive Brain Stimulation on Impulsivity in 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)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal

Montreal, Quebec, H1N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroConn

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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