Home-Based tDCS for Depression in BPD

Официальное название

Efficacy Study of Enhanced Home-Based Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms in Borderline Personality Disorder (BPD): A Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

Background Major Depressive Disorder (MDD) is 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 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 randomized, following a two-week online psychoeducation, to receive either active or sham tDCS in 14 sessions over one week. The primary outcome is the feasibility of home-based tDCS in remote and urban areas. 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 analyses will evaluate the impact of tDCS on neuropsychological functioning, physical activity, and substance use. Sociodemographic variables will be considered in predicting treatment response. 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 the feasibility of tDCS in real-world settings, contributing to the development of scalable neuromodulation strategies for individuals with BPD and comorbid depression.

Вмешательства

• Устройство 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:
• Процедура 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.
• Процедура 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.
• Устройство 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

Первичные конечные точки

• Feasibility and Acceptability of Home-Based tDCS [Срок оценки: 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]

Вторичные конечные точки (12)

• Borderline Symptom List (BSL-23) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Pre-intervention (immediately prior to tDCS/sham) and Month 3.]
• Personality Disorder Severity Scale (PDS-ICD-11) [Срок оценки: Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham).]
• Barratt Impulsiveness Scale (BIS-11) [Срок оценки: 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.]
• World Health Organization Disability Assessment Schedule (WHODAS 2.0, 12-item version) [Срок оценки: 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.]
• Beck Anxiety Inventory (BAI) [Срок оценки: 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.]
• Antidepressant Treatment History Form - Short Form (ATHF-SF) [Срок оценки: Baseline.]
• Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [Срок оценки: 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.]
• Pittsburg Sleep Questionnaire Inventory (PSQI) [Срок оценки: 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.]
• Psychophysiological parameters [Срок оценки: 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.]
• The Personality Inventory for DSM-5 (PID-5) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• IUSMM — Montreal

Публикации

• Cailhol L, Soltani K, Benrimoh D, Blay M, Brodeur S, Brunelin J, Dussault C, Hoyer R, Mills J, Poirier S, Potvin S, Roy D, Roy O, Ruocco A, Savard C, St-Amour S, Laureys S. Enhanced home-based transcranial direct-current stimulation (tDCS) for depression comorbid with borderline personality disorder (BPD): study protocol for a pilot double-blinded randomised controlled trial (TENTADIS). BMJ Open. PMID 42476741

Идентификаторы

NCT: NCT06972368 · 2025-4050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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