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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453032
• Other study ID #: 2021-2308
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: February 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 20, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Impulsive Behavior
• Personality Disorders

Intervention

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)

Locations

Country	Name	City	State
Canada	Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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 Neuropsyc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	3 months
Secondary	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	2 weeks
Secondary	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.	2 weeks