Testing tDCS with Treatment as Usual against a placebo for major depressive disorder (MDD)
Official title: Home-Based tDCS for Depression in BPD
Efficacy Study of Enhanced Home-Based Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms in Borderline Personality Disorder (BPD): A Pilot Randomized Controlled Trial
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
Canadian Sites (1)
IUSMM
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
Exclusion
- −\. To be pregnant. 8. To be currently undergoing neuromodulation treatment. 9. To be currently using benzodiazepines.
- −\- 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: tDCS, Treatment as Usual (TAU), Psychoeducation, ShamSham procedureA procedure made to feel like the real one, without the active step.Read more →-tDCS.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/shamSham procedureA procedure made to feel like the real one, without the active step.Read more →), Post-intervention (within 1 day after of tDCS/sham), Month 3.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility and Acceptability of Home-Based tDCS — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/shamSham procedureA procedure made to feel like the real one, without the active step.Read more →), Post-intervention (within 1 day after of tDCS/sham), Month 3.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06972368 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About tDCSDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About PsychoeducationProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Sham-tDCSDevice
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
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/shamSham procedureA procedure made to feel like the real one, without the active step.Read more →), Post-intervention (within 1 day after of tDCS/sham), Month 3.
The study as a whole is currently expected to finish around 2027-06-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.