Intensive tDCS for MDD: Feasibility Study
- Conditions
- Major Depressive Disorder
- Interventions
- Device: transcranial direct current stimulation (tDCS)
- Registration Number
- NCT05194267
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief Summary
This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.
- Detailed Description
This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Secondary objective is to gather preliminary data on the clinical effects of the protocol. After assessment and inclusion into the study, participants will receive up to 50 tDCS sessions over 10 days.
Study procedures:
Daily assessments: brief questions before and after each tDCS session to evaluate potential adverse events as well as a verbal rating scale for pain.
Questionnaires : a battery of mood questionnaires will be completed to inform findings regarding clinical effects of the treatment.
Cognitive measures: a short cognitive assessment will be completed to inform findings regarding cognitive safety of the treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Diagnosis of Major unipolar depression for at least 4 weeks meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
- Age between 18 to 65
- Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD)
- Bipolar disorder,
- Psychosis
- Active substance use disorder (in the last 3 months)
- Personality disorder
- Neurocognitive disorder
- High risk of suicide
- Major comorbid medical or neurological condition
- Pregnancy
Medical contraindications to tDCS:
- Ferromagnetic material in the skull
- Defect in the bone substance of the skull
- Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.)
- Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active tDCS transcranial direct current stimulation (tDCS) Will be receiving active intensive tDCS treatment
- Primary Outcome Measures
Name Time Method Feasibility-related endpoints - adherence to tDCS after 10 days of treatment sessions Number of completed treatment sessions
Adverse Events reported up to one month after end of the treatment Adverse Events reported
Feasibility-related endpoints - retention rates after 10 days of treatment sessions number of patients who did not completed the total (50) sessions
- Secondary Outcome Measures
Name Time Method Percentage change on Patient Health Questionnaire (PHQ-9) T0 (baseline) and T2 (one month after the end of the treatment) Percentage change on Patient Health Questionnaire (PHQ-9)
Response rate (> 50% improvement) and remission rate (score <7) using GRID-Hamilton Depression Rating Scale (GRID-HAMD) T1 (one week after end of the treatment) and T2 (one month after end of the treatment) Response rate (\> 50% improvement) and remission rate (score \<7) using GRID-HAMD scale. (score 0-7= not depressed; very severe \>23).
Percentage change on Hamilton Rating Scale for Depression (HAMD-6) T0 (baseline) and T2 (one month after the end of the treatment) Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
Percentage change on Rey Auditory Verbal Learning Scale (RAVLT). T0 (baseline) and T1 (one week after end of the treatment) Cognitive safety. Percentage change on Rey Auditory Verbal Learning Scale. total learning. (Minimum score 0 and maximum score 75, higher score means better outcome)
Percentage change on Rey-Osterrieth Complex Figure (ROCF) T0 (baseline) and T1 (one week after end of the treatment) Percentage change on Rey-Osterrieth Complex Figure (ROCF), total score immediate recall. (Minimum score 0 and maximum score 36, higher score means better outcome
Percentage change on General Anxiety Disorder (GAD-7) T0 (baseline) and T2 (one month after the end of the treatment) Percentage change on General Anxiety Disorder (GAD-7)
Percentage change on Trail Making Test parts A&B T0 (baseline) and T1 (one week after end of the treatment) Percentage change on Trail Making Test. Total time needed for completion on part B. (no minimum and maximum time)
Percentage change on the Controlled Oral Word Association (COWAT) T0 (baseline) and T1 (one week after end of the treatment) Percentage change on the Controlled Oral Word Association (COWAT). (Minimum score: 0; Maximum score: no maximum; higher score means better outcome).
Trial Locations
- Locations (1)
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada