Intensive tDCS for MDD: Feasibility Study (tDCSintensif)

Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3J4
      • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9)	This outcome reflects the percentage change in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing depressive symptoms over the past 2 weeks. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), with a total score ranging from 0 to 27. Higher scores indicate more severe depression. Percentage change from baseline (T0) was calculated at two follow-up timepoints: T1 = 1 week after end of treatment (Day 17); T2 = 1 month after end of treatment (Day 40) Percentage change was calculated using the formula: ((T_follow-up - T0) / T0) × 100. A negative value indicates improvement.	T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate (> 50% improvement) and remission rate (score <7) using GRID-Hamilton Depression Rating Scale (GRID-HAMD)	Response rate (> 50% improvement) and remission rate (score <7) using GRID-HAMD scale. (score 0-7= not depressed; very severe >23).	T1 (one week after end of the treatment) and T2 (one month after end of the treatment)
Percentage change on Hamilton Rating Scale for Depression (HAMD-6)	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 Patient Health Questionnaire (PHQ-9)	Percentage change on Patient Health Questionnaire (PHQ-9)	T0 (baseline) and T2 (one month after the end of the treatment)
Percentage change on General Anxiety Disorder (GAD-7)	Percentage change on General Anxiety Disorder (GAD-7)	T0 (baseline) and T2 (one month after the end of the treatment)
Percentage change on Rey Auditory Verbal Learning Scale (RAVLT).	Cognitive safety. Percentage change on Rey Auditory Verbal Learning Scale. total learning. (Minimum score 0 and maximum score 75, higher score means better outcome)	T0 (baseline) and T1 (one week after end of the treatment)
Percentage change on Rey-Osterrieth Complex Figure (ROCF)	Percentage change on Rey-Osterrieth Complex Figure (ROCF), total score immediate recall. (Minimum score 0 and maximum score 36, higher score means better outcome	T0 (baseline) and T1 (one week after end of the treatment)
Percentage change on Trail Making Test parts A&B	Percentage change on Trail Making Test. Total time needed for completion on part B. (no minimum and maximum time)	T0 (baseline) and T1 (one week after end of the treatment)
Percentage change on the Controlled Oral Word Association (COWAT)	Percentage change on the Controlled Oral Word Association (COWAT). (Minimum score: 0; Maximum score: no maximum; higher score means better outcome).	T0 (baseline) and T1 (one week after end of the treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interim Analysis-GRID-Hamilton Depression Rating Scale (GRID-HAMD)	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.	After the first 10 patients are completed

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Jean-Philippe Miron, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2022-9546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No