Back to resultsThe Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NeuroConn
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring impulsivity, Non-Invasive Brain Stimulation, Psychotherapy
Eligibility Criteria
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
Sites / Locations
- Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI)
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)
The Effect of tDCS on Risk taking ( an impulsive behavior dimension)
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
the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS))
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.
Full Information
NCT ID
NCT05453032
First Posted
March 29, 2022
Last Updated
February 11, 2023
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)
1. Study Identification
Unique Protocol Identification Number
NCT05453032
Brief Title
The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
Official Title
Effects of Transcranial Direct Current Stimulation in Conjugation With Psychotherapy on Impulsivity in Patients With Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)
4. Oversight
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
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
impulsivity, Non-Invasive Brain Stimulation, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NeuroConn
Other Intervention Name(s)
tDCS, transcranial Direct Current Stimulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
The effect of NIBS on impulsivity (UPPS- Behavioral Impulsive scale)
Description
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.
Time Frame
2-week stimulation session
Secondary Outcome Measure Information:
Title
The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI)
Description
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)
Time Frame
3 months
Title
The Effect of tDCS on Risk taking ( an impulsive behavior dimension)
Description
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
Time Frame
2 weeks
Title
the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS))
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are planning to share the results only while keeping the coincidentally for the participants
Citations:
PubMed Identifier
32622171
Citation
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.
Results Reference
background
PubMed Identifier
35176417
Citation
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.
Results Reference
background
PubMed Identifier
31715284
Citation
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.
Results Reference
result
Learn more about this trial
The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
We'll reach out to this number within 24 hrs