Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 11:49 AM
Study NCT ID:
NCT06972368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based tDCS for Depression in BPD
Sponsor:
Ciusss de L'Est de l'Île de Montréal
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENTADIS
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: