Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2026-01-01
2027-06-01
Brief Summary
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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.
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Detailed Description
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Methods This double-blind randomized controlled trial (RCT) will assess the efficacy of home-based tDCS in reducing depressive symptoms in BPD patients who are experiencing moderate to severe depressive episodes. A total of 60 participants will be randomly assigned to either active or sham tDCS for 14 sessions over two weeks. The primary outcome is the remission rate according to the Montgomery-Åsberg Depression Rating Scale (MADRS) scores six weeks after treatment initiation. Secondary outcomes include changes in BPD symptom severity, anxiety, sleep quality, and functional impairment. Exploratory analyses will evaluate the impact of tDCS on neuropsychological functioning, physical activity, and addiction. Sociodemographic variables will be considered in predicting treatment response. Feasibility and acceptability outcomes will also be assessed, including patient adherence and satisfaction (visual analog score). All assessments will be conducted at baseline, post-treatment, and during follow-ups up to three months after treatment ends.
Discussion The findings will address both the clinical efficacy and feasibility of tDCS in real-world settings, contributing to the development of scalable neuromodulation strategies for individuals with BPD and comorbid depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
7\. To be pregnant. 8. To be currently undergoing neuromodulation treatment. 9. To be currently using benzodiazepines.
18 Years
65 Years
ALL
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Locations
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IUSMM
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-4050
Identifier Type: -
Identifier Source: org_study_id
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