Intensive tDCS for MDD: Feasibility Study

Major Depressive Disorder Clinical Trial

— tDCSintensif  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194267
• Other study ID #: 2022-9546
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: April 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Feasibility-related endpoints - adherence to tDCS	Number of completed treatment sessions	after 10 days of treatment sessions
Primary	Feasibility-related endpoints - retention rates	number of patients who did not completed the total (50) sessions	after 10 days of treatment sessions
Primary	Adverse Events reported	Adverse Events reported	up to one month after end of the treatment
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)