Home-Based tDCS for Depression in BPD (TENTADIS)

Ciusss de L'Est de l'Île de Montréal

Status: Enrolling

Conditions: Borderline Personality Disorders; Major Depressive Disorder (MDD)

Treatments: Device: Sham-tDCS; Device: tDCS; Procedure: Treatment as Usual (TAU); Procedure: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06972368

2025-4050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

tDCS

Experimental group

Description:

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.

Treatment:

Procedure: Psychoeducation

Procedure: Treatment as Usual (TAU)

Device: tDCS

Sham tDCS

Placebo Comparator group

Description:

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:

Procedure: Psychoeducation

Procedure: Treatment as Usual (TAU)

Device: Sham-tDCS