tDCSintensif: Intensive tDCS for MDD: Feasibility Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active tDCS Will be receiving active intensive tDCS treatment |
Device: transcranial direct current stimulation (tDCS)
tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression
|
Outcome Measures
Primary Outcome Measures
- Feasibility-related endpoints - adherence to tDCS [after 10 days of treatment sessions]
Number of completed treatment sessions
- Feasibility-related endpoints - retention rates [after 10 days of treatment sessions]
number of patients who did not completed the total (50) sessions
- Adverse Events reported [up to one month after end of the treatment]
Adverse Events reported
Secondary Outcome Measures
- 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 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)
- 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 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 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).
Other Outcome Measures
- Interim Analysis-GRID-Hamilton Depression Rating Scale (GRID-HAMD) [After the first 10 patients are completed]
Interim analysis to review response (GRID-HAMD) after 10 patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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) and the Mini International Neuropsychiatric Interview (M.I.N.I)
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Age between 18 to 65
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Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD)
Exclusion Criteria:
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Bipolar disorder,
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Psychosis
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Active substance use disorder (in the last 3 months)
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Personality disorder
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Neurocognitive disorder
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High risk of suicide
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Major comorbid medical or neurological condition
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Pregnancy
Medical contraindications to tDCS:
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Ferromagnetic material in the skull
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Defect in the bone substance of the skull
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Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.)
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Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec | Canada | H2X 3J4 |
Sponsors and Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
- Principal Investigator: Jean-Philippe Miron, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-9546