Home-Based tDCS for Depression in BPD

NCT06972368 | Recruiting FDA Device

• 1 other identifier: 2025-4050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Neuromodulation; personality; tDCS; Depression

Outcome Measures

Primary Outcomes (1)

• Feasibility and Acceptability of Home-Based tDCS

  * Recruitment Rate: Percentage of eligible patients agreeing to participate. * Adherence Rate: Over 75% of participants completed at least 12 of the 14 tDCS sessions scheduled * Participant Satisfaction: Assessed using a Visual Analog Scale (VAS) at V5. * Tolerability: The questionnaire of sensations related to transcranial electrical stimulation (TES) is administered after each tDCS stimulation session to assess tolerability and monitor potential adverse effects. This questionnaire evaluates common side effects, including itching, tingling, burning sensations, headache, discomfort, and dizziness. One time per week, the questionnaire will add a question on suicidal ideation. We will use the cumulative percentage of side effects for all sessions (one week of stimulation). * Acceptability of psychoeducation: Adherence Rate: Percentage of patients completing 90% of psychoeducation (at least 9 videos) according to the Moodle online course

  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

Secondary Outcomes (15)

• Borderline Symptom List (BSL-23)

  Baseline (Day 0), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Week 6 and Month 3.

• Quick Inventory of Depressive Symptomatology (QIDS)

  Baseline (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Week 6 and Month 3.

• Borderline Personality Disorder Severity Index (BPDSI)

  Pre-intervention (immediately prior to tDCS/sham) and Month 3.

• Personality Disorder Severity Scale (PDS-ICD-11)

  Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham).

• Barratt Impulsiveness Scale (BIS-11)

  Baseline (Day 0), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Week 6 and Month 3.

Study Arms (2)

tDCS

EXPERIMENTAL

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.

Device: tDCS; Procedure: Treatment as Usual (TAU); Procedure: Psychoeducation

Sham tDCS

PLACEBO COMPARATOR

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.

Procedure: Treatment as Usual (TAU); Procedure: Psychoeducation; Device: Sham-tDCS

Interventions

tDCS DEVICE

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.

tDCS

Treatment as Usual (TAU) PROCEDURE

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.

Sham tDCS; tDCS

Psychoeducation PROCEDURE

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; tDCS

Sham-tDCS DEVICE

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

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

IUSMM

Montreal, Quebec, H1N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Borderline Personality Disorder; Depression

Interventions

Transcranial Direct Current Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personality Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Lionel Cailhol, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available 12 months after publication of the main results and for a period of 5 years.
• Access Criteria: Researchers must submit a methodologically sound proposal describing the purpose of the data use. Requests will be reviewed by the study's principal investigator and data access committee. A data-sharing agreement will be required.

Locations

CA (1)