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Borderline Personality DisorderTIMBERNCT03498937

Effects of tDCS on Impulsiveness Among People Suffering From Borderline Personality Disorder

A study testing Active tDCS in people with Borderline Personality Disorder and Impulsive Behavior, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Active tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesFrance
Study dates
May 2019to Dec 2020
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man or woman older than 18 years old
  • Right-handed
  • Signed Informed Consent form
  • Subject affiliated to or beneficiary from a French social security regime
  • Inpatient or outpatient at the Adult Psychiatry Service
  • Diagnosis of Borderline Personality Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the Structured Clinical Interview for DSM Disorders (SCID-II)
  • Absence of addictive comorbidities (except: tobacco, tea, coffee)
  • Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)

Who cannot join

  • Younger than 18 years old
  • Left-handed
  • Subject under measure of protection or guardianship of justice
  • Presence of psychiatric comorbidities (chronic psychosis, Bipolar Disorder)
  • Subject beneficiary from a legal protection regime
  • Subject unlikely to cooperate or low cooperation stated by investigator
Show all 9Show fewer
  • Subject not covered by social security
  • Pregnant woman
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File"

Trial locations and contacts

3 sites in 1 country.

Djamila BENNABI, MD PhD contact

+33381219007

dbennabi@chu-besancon.fr

Magali NICOLIER, PhD contact

+33381219007

mnicolier@chu-besancon.fr

France3 sites

  • CHU Besancon

    Besançon, Franche-Comte, 25000

    Djamila BENNABI, MD PhD, +33381219007, dbennabi@chu-besancon.fr

    Magali NICOLIER, PhD, +33381219007, mnicolier@chu-besancon.fr

  • Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy

    Nancy

    Raymund Schwan, MD PhD, raymund.schwan@univ-lorraine.fr

  • Centre Hospitalier Spécialisé de Rouffach

    Rouffach

    Fabrice Duval, MD, f.duval@ch-rouffach.fr

Other trials in France

About this study

Official title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER

The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.

Read the detailed description

Impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behavior, is recognized as a major factor involved in suicidal behavior and self-harm behaviors. It consists in one of the diagnostic criteria of Borderline Personality Disorder, allowing as well assessment of its clinical severity. There is so far no specific treatment concerning impulsivity. From a neurobiological perspective, the prefrontal cortex is considered as a critical region in the cognitive control of behaviors. Previous studies have associated an hypoactivation of the dorsolateral prefrontal cortex (dlPFC) and the dorsal part of the anterior cingulate cortex to Borderline Personality Disorder.

Transcranial direct current stimulation (tDCS) is a technique of noninvasive brain stimulation which delivers a subthreshold electrical current to the scalp, manipulating the resting membrane potential. It has shown cognitive function improvement, both in healthy individuals and psychiatric populations. Modulation of the dlPFC could therefore represent a mean of reducing impulsivity in those patients.

With a prospective, sham-controlled, crossover, double-blind design, this study aims to evaluate the impact of bilateral tDCS over the dlPFC on the impulsive dimension of adults suffering from Borderline Personality Disorder. Subjects will be submitted to 10 tDCS stimulation sessions (active or sham) for five consecutive days (2 sessions of 30 minutes/day). Current intensity will be of 2 mA, through 25 cm² surface electrodes, placed over the dlPFC (anode position over F4 and cathode over F3, according to the EEG 10-20 international system). Subjects who undergo active stimulation sessions will be then submitted to sham sessions and vice-versa. Baseline measures will be compared to those obtained immediately after the end of sessions (5 days: short-term effects), and to 12 and 30 days later (long-term effects). Active and sham stimulation sessions outcomes will as well be compared.

Being tested
Active tDCS, Sham tDCS
Keywords
Borderline Personality Disorder, Impulsive behavior, Suicidal behavior, Cognitive control, tDCS, Noninvasive brain stimulation
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.

  • Active tDCSDevice

    Also called Starstim® (Neuroelectrics, Spain)

    10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC

  • Sham tDCSDevice

    Also called Starstim® (Neuroelectrics, Spain)

    10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC

Study groups in NCT03498937
Study groupRoleWhat they receive
Group 1ExperimentalSubjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 active tDCS sessions, followed by 10 sham tDCS sessions
Receives: Device: Active tDCS; Device: Sham tDCS
Group 2ExperimentalSubjects suffering from Borderline Personality Disorder randomly assigned to start the trial by 10 sham tDCS sessions, followed by 10 active tDCS sessions
Receives: Device: Active tDCS; Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EPs during BART

    Amplitude variation of evoked potentials (EPs) detected by electroencephalography (EEG) during the Balloon Analogue Risk Task (BART), assessing risk-taking behavior. Variation will be obtained by comparing records before beginning of stimulation sessions with 5, 12 and 30 days after active and/or sham tDCS.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

Secondary outcomes (7)

  1. BIS-10 scores

    Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  2. HDRS scores

    Compared scores from the Hamilton Depression Rating Scale (HDRS). The HDRS is a clinician-rated 17 item scale which allows depression severity assessment and follow-up. Each item is scored on a 3 or 5 point scale. Scores are represented as follows: 0-7 Normal, 8-13 Mild Depression, 14-18 Moderate Depression, 19-22 Severe Depression, ≥23 Very Severe Depression.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  3. UPPS-P scores

    Compared scores from the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency Impulsive Behavior Scale (UPPS-P). The French version of the UPPS-P is a self-rated 45 item scale, evaluating the following components: urgency, lack of premeditation, lack of perseverance and sensation seeking. Each item is scored on a base of 4 points. Higher scores indicate higher levels of impulsivity.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  4. MADRS scores

    Compared scores from the Montgomery and Asberg Depression Rating Scale (MADRS). The MADRS is clinician-rated 10 item scale, scored in a base of 6 points per item. Cutoff points are: 0-6 Asymptomatic, 7-19 Mild Depression, 20-34 Moderate Depression and >34 Severe Depression.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  5. C-SSRS scores

    Compared scores from the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a clinician-rated tool that evaluates suicidal ideation and behavior. It is composed by 6 "yes/no" questions. High suicide risk is indicated when "yes" is answered to questions 4, 5 or 6.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  6. Go/No-Go task

    Compared results from the experimental Go/No-Go task, assessing response inhibition.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

  7. Stroop task

    Compared results from the experimental Stroop task, assessing response inhibition.

    Measured: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study startMay 2019 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03498937
Sponsor's protocol ID
P/2017/319
Acronym
TIMBER
Status last verified
Apr 2018
First submitted
9 Apr 2018
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PubMed 32368793

  • Teti Mayer J, Nicolier M, Gabriel D, Masse C, Giustiniani J, Compagne C, Vandel P, Pazart L, Haffen E, Bennabi D. Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial. Trials. 2019 Jun 10;20(1):347. doi: 10.1186/s13063-019-3427-z.

    PubMed 31182143

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS in people with Borderline Personality Disorder and Impulsive Behavior, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.

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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Djamila BENNABI, MD PhD (+33381219007, dbennabi@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EPs during BART (time frame: Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS). 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 NCT03498937, which also lists 2 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 7 Mar 2019.

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