Home-Based tDCS for Depression in BPD

NCT06972368 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

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.

PROCEDURE

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.

PROCEDURE

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.

DEVICE

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2027-06-01
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972368 on ClinicalTrials.gov