Intensive tDCS for MDD: Feasibility Study (tDCSintensif)

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: transcranial direct current stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05194267

2022-9546

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.)