Clinical trial NCT06972368: Home-Based tDCS for Depression in BPD
Official title: Efficacy Study of Enhanced Home-Based Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms in Borderline Personality Disorder (BPD): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Borderline Personality Disorders
Keywords: Neuromodulation
personality
tDCS
Depression
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if home-based transcranial direct current stimulation (tDCS) can reduce depressive symptoms in adults diagnosed with Borderline Personality Disorder (BPD) who are experiencing moderate to severe depression.

The main questions it aims to answer are:

* Does active tDCS reduce depressive symptoms more effectively than sham stimulation?
* Can home-based tDCS also improve anxiety, sleep, cognitive functioning, and other associated symptoms?

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.

Detailed description: Abstract Background Depressive disorders are the most common comorbidity among individuals with Borderline Personality Disorder (BPD), affecting over 85% of patients and leading to high recurrence rates and resistance to treatment. Traditional pharmacological and psychotherapeutic interventions often show limited efficacy in this population, highlighting the need for innovative treatment strategies. Emerging evidence suggests that the dorsolateral prefrontal cortex (DLPFC) plays a crucial role in the pathophysiology of both Major Depressive Disorder (MDD) and BPD. In addition, non-invasive brain stimulation, particularly transcranial Direct Current Stimulation (tDCS), has shown promising results in alleviating depression and improving BPD symptoms when targeting the DLPFC. The development of home-based tDCS presents new opportunities for accessible and cost-effective interventions. However, no study has specifically investigated its effects on MDD in the context of BPD.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 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; primary endpoint at Week 6 after initial stimulation.
Secondary outcomes:
measure: Borderline Symptom List (BSL-23)
timeFrame: 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.
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: 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.
measure: Borderline Personality Disorder Severity Index (BPDSI)
timeFrame: Pre-intervention (immediately prior to tDCS/sham) and Month 3.
measure: Personality Disorder Severity Scale (PDS-ICD-11)
timeFrame: Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham).
measure: Barratt Impulsiveness Scale (BIS-11)
timeFrame: 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.
measure: World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version)
timeFrame: 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.
measure: Beck Anxiety Inventory (BAI)
timeFrame: 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.
measure: Antidepressant Treatment History Form - Short Form (ATHF-SF)
timeFrame: Baseline.
measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: 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.
measure: Pittsburg Sleep Questionnaire Inventory (PSQI)
timeFrame: This assessment will be administered at multiple time points: inclusion, pre-randomization, immediately after tDCS or sham stimulation, six weeks post-stimulation, and three months post-stimulation.
measure: Psychophysiological parameters
timeFrame: The wristwatch will be worn starting from the second visit-one week after inclusion-until just after the tDCS or sham-tDCS session, two weeks later.
measure: The Personality Inventory for DSM-5 (PID-5)
timeFrame: 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.
measure: N-back task
timeFrame: This assessment will be administered at two time points: one week after inclusion and immediately after the tDCS or sham stimulation.
measure: Go/No-Go
timeFrame: This assessment will be administered at two time points: one week after inclusion and immediately after the tDCS or sham stimulation.
Other outcomes:
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