Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05194267
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intensive tDCS for MDD: Feasibility Study
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
Study Overview
Official Title:
Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tDCSintensif
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: