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Completed

NCT Number: NCT05194267

Intensive tDCS for MDD: 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

About this 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). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression

Primary outcomes

  1. Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-9)

    Time frame: T0 (baseline), T1 (1 week after end of treatment) and T2 (one month after the end of the treatment)

    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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: tDCSintensif

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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