Recruiting

tDCS

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06972368

Conditions

Major Depressive Disorder (MDD)

Borderline Personality Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

tDCS

Treatment as Usual (TAU)

Psychoeducation

Sham-tDCS

Study Details

Brief summary:

The present study aims to assess the feasibility of home-based tDCS in remote and urban areas (primary objective).

The secondary aim is to obtain a preliminary assessment of the efficacy of 14 home-based tDCS sessions in reducing depressive symptoms in BPD patients with moderate to severe depressive episodes and BPD symptoms.

Exploratory objectives include assessing the impact on neuropsychological and psychosocial functioning, anxiety, physical activity, sleep disorders, and addiction.

Additionally, we aim to investigate the sociodemographic and clinical factors that are linked to the most favorable response to tDCS in addressing both depressive and BPD symptoms.

We also aim to assess the feasibility of using a smartwatch as an outcome measure in this population.

Finally, we intend to gather preliminary data on the effectiveness of an online psychoeducational program specifically designed for patients with BPD.

Researchers will compare active tDCS to sham tDCS to see if active treatment is more effective in treating depression in this population.

Participants will:

  • Receive 14 sessions of either active or sham tDCS over one week, delivered at home
  • Complete psychological and neurocognitive assessments at baseline, post-treatment, and at 6 weeks
  • Wear actigraphy monitors and complete questionnaires to assess sleep, physical activity, and other mental health outcomes

This trial will also explore the feasibility of delivering tDCS in both urban and rural settings.

Conditions

Major Depressive Disorder (MDD)

Borderline Personality Disorders

Study ID

NCT06972368

Start date

Jan 1, 2026

Status verified date

May, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. To be aged between 18 and 65.
2. To meet the DSM-IV criteria for BPD.
3. To present a moderate depressive episode, defined as a MADRS score ≥ 20 (V1 and V3).
4. To be capable to consent to participate in the study.
5. To speak either French or English.
6. Participants must have a prescribing doctor or mental health professional responsible
7. To maintain a stable psychopharmacological and psychotherapeutic intervention.
8. To have access to internet an a smartphone.
9. To demonstrate proficiency in independently using a tDCS device.
10. To be able to pick up and return the remote tDCS device.

Exclusion Criteria:

\- 1. To have a history of Epilepsy. 2. To have a contraindication for tDCS Medical Devices. 3. To have a history of Cerebrovascular Surgery. 4. To present scalp Conditions Affecting tDCS Electrode Placement. 5. To have a history of bipolar disorder. 6. To present social or medical conditions limiting the autonomous use of remote tDCS.

7\. To be pregnant. 8. To be currently undergoing neuromodulation treatment. 9. To be currently using benzodiazepines.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS

14 sessions of active tDCS, twice daily, each lasting 30 minutes and separated by an interval of minimum at 2 hours. Ideally, sessions will be scheduled at the same time each day.

placebo comparator: Sham tDCS

14 sessions of sham tDCS, twice daily, each lasting 30 minutes and separated by an interval of minimum at 2 hours. Ideally, sessions will be scheduled at the same time each day.

Interventions

tDCS

Description:

Participants randomized to this arm will receive 14 sessions of home-based transcranial Direct Current Stimulation (tDCS), administered twice daily for 30 minutes over 7 consecutive days. Each session will use a 2mA current with a SNAPstrap™ montage targeting the left dorsolateral prefrontal cortex (F3) with the anode and the right DLPFC (F4) with the cathode. Sessions include a 30-second ramp-up and ramp-down. The total delivered charge will be 48 coulombs.

Enhancement component:

Each session will be paired with cognitive and emotional enhancement strategies:

Emotion regulation script (DBT-inspired, personalized and pre-written based on a moderately dysregulated situation).

Cognitive training via Lumosity, targeting executive functions and memory.

Treatment as Usual (TAU)

Description:

Throughout the study, participants are required to maintain stable pharmacological and psychotherapeutic regimens, defined as:

No changes in medications or therapy for at least 6 weeks after tDCS initiation.

TAU is provided by participants' regular treating physician or mental health professional, independent of the study team.

TAU includes psychotropic medication, psychotherapy, and case management, as clinically indicated.

Psychoeducation

All participants receive access to a structured online psychoeducation program before randomization.

This includes:

  • Short videos (8-14 minutes each) covering BPD, depression, neuromodulation, therapeutic success factors, and tDCS.
  • Multiple-choice quizzes (MCQs) to ensure comprehension.
  • Delivered in French with English subtitles. Designed to improve understanding of BPD and associated treatments, including the rationale for tDCS.

Sham-tDCS

Description:

Participants randomized to this arm will receive 14 sessions of sham tDCS, with identical scheduling and device setup as the active condition. The session mimics real tDCS (same SNAPstrap montage, ramp-up and ramp-down of 30 seconds), but no current is delivered after the initial 30 seconds.

Enhancement component:

Participants follow the same emotional regulation script and Lumosity cognitive training during

Primary outcome measure

  • Feasibility and Acceptability of Home-Based tDCS [ Time Frame: Baseline (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Month 3 ]

Central Contacts and Locations

Central contacts

Lionel Cailhol, MD, PhD

514-251-4000lionel.cailhol.med@ssss.gouv.qc.ca

Locations

IUSMM

Recruiting

Montreal, Quebec, Canada, H1N3M5

Contacts

Lionel Cailhol, MD, PhD

lionel.cailhol.med@ssss.gouv.qc.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

May 6, 2026

Last verified

May, 2025

Keywords

  • Neuromodulation
  • personality
  • tDCS
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2026-05-06.