Home-based transcranial direct current stimulation (tDCS) for depression in borderline personality disorder
Efficacy Study of Enhanced Home-Based Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms in Borderline Personality Disorder (BPD): A Pilot Randomized Controlled Trial
NA · Ciusss de L'Est de l'Île de Montréal · NCT06972368
This project will see if 14 home-based tDCS sessions, compared with sham, can reduce depressive symptoms in adults with borderline personality disorder and moderate-to-severe depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06972368 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized trial in which 60 adults with DSM-IV borderline personality disorder and a moderate-to-severe depressive episode will be randomized to 14 sessions of active or sham home-based tDCS following a two-week online psychoeducation. Sessions are delivered at home with participants required to pick up and return the device at the study center, and feasibility in both remote and urban settings is the primary outcome. Secondary outcomes include preliminary efficacy on depressive symptoms, while exploratory outcomes examine neuropsychological and psychosocial functioning, anxiety, sleep, physical activity, addiction, and the feasibility of using a smartwatch as an outcome measure. The trial will also explore which sociodemographic and clinical factors predict the best response to tDCS and will compare active stimulation to sham in a blinded design.
Who should consider this trial
Good fit: Adults aged 18–65 with DSM-IV borderline personality disorder experiencing a moderate-to-severe depressive episode (MADRS ≥ 20), who have stable psychiatric care, access to a smartphone and internet, and can independently use and pick up/return a tDCS device are ideal candidates.
Not a fit: People with contraindications to tDCS (for example epilepsy, certain scalp conditions, history of bipolar disorder), pregnancy, or who cannot safely or independently use the device are unlikely to benefit from this home-based intervention.
Why it matters
Potential benefit: If successful, this approach could provide an accessible at-home treatment option to help reduce depressive symptoms and improve functioning for people with BPD.
How similar studies have performed: Noninvasive stimulation of the DLPFC with tDCS has shown promise for depression and some preliminary benefit for BPD symptoms, but home-based tDCS specifically in BPD populations is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- IUSMM — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Lionel Cailhol, MD, PhD
- Email: lionel.cailhol.med@ssss.gouv.qc.ca
- Phone: 514-251-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Borderline Personality Disorders, Neuromodulation, personality, tDCS, Depression