Borderline Personality DisorderNCT05453032
The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
A study testing NeuroConn in people with Borderline Personality Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- NeuroConn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Recherche_ Institut Univesitaire de Santé Mentale à Montréal
Montreal, Quebec, H1N 3M5
About this study
Official title: 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)
- Conditions
- Borderline Personality Disorder
- Being tested
- NeuroConn
- Keywords
- impulsivity, Non-Invasive Brain Stimulation, Psychotherapy
- Medical subject headings
- Borderline Personality Disorder, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroConnDevice
Also called tDCS, transcranial Direct Current Stimulation
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeuroConn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-week stimulation session
Secondary outcomes (3)
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)
Measured: 3 months
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
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start10 May 2021
- Primary completion30 Mar 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)
- Responsible party
- Principal investigator, Ahmad Al Zatam, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453032
- Sponsor's protocol ID
- 2021-2308
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are planning to share the results only while keeping the coincidentally for the participants
Publications
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.
PubMed 32622171Lisoni 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.
PubMed 35176417Teti 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.
PubMed 31715284
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation in Conjugation With Psychotherapy on Impulsivity in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05453032
- Acronym / sponsor ID
- 2021-2308
- Conditions
- Borderline Personality Disorder
- Keywords
- impulsivity, Non-Invasive Brain Stimulation, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Dr. Lionel Cailhol, chef of psychiatry department at Montreal Psychiatric Institute (IUSMM)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- we recruited 10 patients who attended a 10-session of tDCS stimulation. Each session lasted for 20 minutes in a 2-week.
| Arm | Type | Receives |
|---|---|---|
| Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy | Experimental | Device: NeuroConnPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroConnAlso: tDCS, transcranial Direct Current StimulationA 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) | Device | Patients with BPD assigned to the trial of 10 active tDCS sessions followed by psychotherapy |
Primary outcome
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.
3 secondary outcomes
The effect of tDCS on BPD severity overall ( Borderline Personality Disorder Severity Index: BPDSI)
Time frame: 3 months
The Effect of tDCS on Risk taking ( an impulsive behavior dimension)
Time frame: 2 weeks
the effect of tDCS on depressive symptoms in BPD (Montgomery-Asberg Depression Rating Scale (MADRS))
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 32622171Lisoni 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.
- Background: PubMed 35176417Lisoni 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 publication: PubMed 31715284Teti 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.
- Individual participant dataSharing planned: Undecided. We are planning to share the results only while keeping the coincidentally for the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroConn in people with Borderline Personality Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of NIBS on impulsivity (UPPS- Behavioral Impulsive scale) (time frame: 2-week stimulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453032, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.