NCT05453032

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

March 29, 2022

Last Update Submit

February 11, 2023

Conditions

Keywords

impulsivityNon-Invasive Brain StimulationPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • The effect of NIBS on impulsivity (UPPS- Behavioral Impulsive scale)

    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 Outcomes (3)

  • The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI)

    3 months

  • The Effect of tDCS on Risk taking ( an impulsive behavior dimension)

    2 weeks

  • the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS))

    2 weeks

Study Arms (1)

Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy

EXPERIMENTAL

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

Interventions

NeuroConnDEVICE

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)

Also known as: tDCS, transcranial Direct Current Stimulation
Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

Related Publications (3)

  • Lisoni J, Miotto P, Barlati S, Calza S, Crescini A, Deste G, Sacchetti E, Vita A. Change in core symptoms of borderline personality disorder by tDCS: A pilot study. Psychiatry Res. 2020 Sep;291:113261. doi: 10.1016/j.psychres.2020.113261. Epub 2020 Jun 28.

    PMID: 32622171BACKGROUND
  • Lisoni J, Barlati S, Deste G, Ceraso A, Nibbio G, Baldacci G, Vita A. Efficacy and tolerability of Brain Stimulation interventions in Borderline Personality Disorder: state of the art and future perspectives - A systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jun 8;116:110537. doi: 10.1016/j.pnpbp.2022.110537. Epub 2022 Feb 15.

    PMID: 35176417BACKGROUND
  • Teti Mayer J, Chopard G, Nicolier M, Gabriel D, Masse C, Giustiniani J, Vandel P, Haffen E, Bennabi D. Can transcranial direct current stimulation (tDCS) improve impulsivity in healthy and psychiatric adult populations? A systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 2;98:109814. doi: 10.1016/j.pnpbp.2019.109814. Epub 2019 Nov 9.

MeSH Terms

Conditions

Borderline Personality DisorderImpulsive Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: we recruited 10 patients who attended a 10-session of tDCS stimulation. Each session lasted for 20 minutes in a 2-week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

March 29, 2022

First Posted

July 12, 2022

Study Start

May 10, 2021

Primary Completion

March 30, 2022

Study Completion

July 20, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations