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Intensive tDCS for MDD: Feasibility Study (tDCSintensif)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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) and the Mini International Neuropsychiatric Interview (M.I.N.I)
  • 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.)

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active tDCS

Arm Description

Will be receiving active intensive tDCS treatment

Outcomes

Primary Outcome Measures

Feasibility-related endpoints - adherence to tDCS
Number of completed treatment sessions
Feasibility-related endpoints - retention rates
number of patients who did not completed the total (50) sessions
Adverse Events reported
Adverse Events reported

Secondary Outcome Measures

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).
Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
Percentage change on Patient Health Questionnaire (PHQ-9)
Percentage change on Patient Health Questionnaire (PHQ-9)
Percentage change on General Anxiety Disorder (GAD-7)
Percentage change on General Anxiety Disorder (GAD-7)
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)
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
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)
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).

Full Information

First Posted
December 16, 2021
Last Updated
September 14, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05194267
Brief Title
Intensive tDCS for MDD: Feasibility Study
Acronym
tDCSintensif
Official Title
Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Will be receiving active intensive tDCS treatment
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression
Primary Outcome Measure Information:
Title
Feasibility-related endpoints - adherence to tDCS
Description
Number of completed treatment sessions
Time Frame
after 10 days of treatment sessions
Title
Feasibility-related endpoints - retention rates
Description
number of patients who did not completed the total (50) sessions
Time Frame
after 10 days of treatment sessions
Title
Adverse Events reported
Description
Adverse Events reported
Time Frame
up to one month after end of the treatment
Secondary Outcome Measure Information:
Title
Response rate (> 50% improvement) and remission rate (score <7) using GRID-Hamilton Depression Rating Scale (GRID-HAMD)
Description
Response rate (> 50% improvement) and remission rate (score <7) using GRID-HAMD scale. (score 0-7= not depressed; very severe >23).
Time Frame
T1 (one week after end of the treatment) and T2 (one month after end of the treatment)
Title
Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
Description
Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
Time Frame
T0 (baseline) and T2 (one month after the end of the treatment)
Title
Percentage change on Patient Health Questionnaire (PHQ-9)
Description
Percentage change on Patient Health Questionnaire (PHQ-9)
Time Frame
T0 (baseline) and T2 (one month after the end of the treatment)
Title
Percentage change on General Anxiety Disorder (GAD-7)
Description
Percentage change on General Anxiety Disorder (GAD-7)
Time Frame
T0 (baseline) and T2 (one month after the end of the treatment)
Title
Percentage change on Rey Auditory Verbal Learning Scale (RAVLT).
Description
Cognitive safety. Percentage change on Rey Auditory Verbal Learning Scale. total learning. (Minimum score 0 and maximum score 75, higher score means better outcome)
Time Frame
T0 (baseline) and T1 (one week after end of the treatment)
Title
Percentage change on Rey-Osterrieth Complex Figure (ROCF)
Description
Percentage change on Rey-Osterrieth Complex Figure (ROCF), total score immediate recall. (Minimum score 0 and maximum score 36, higher score means better outcome
Time Frame
T0 (baseline) and T1 (one week after end of the treatment)
Title
Percentage change on Trail Making Test parts A&B
Description
Percentage change on Trail Making Test. Total time needed for completion on part B. (no minimum and maximum time)
Time Frame
T0 (baseline) and T1 (one week after end of the treatment)
Title
Percentage change on the Controlled Oral Word Association (COWAT)
Description
Percentage change on the Controlled Oral Word Association (COWAT). (Minimum score: 0; Maximum score: no maximum; higher score means better outcome).
Time Frame
T0 (baseline) and T1 (one week after end of the treatment)
Other Pre-specified Outcome Measures:
Title
Interim Analysis-GRID-Hamilton Depression Rating Scale (GRID-HAMD)
Description
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.
Time Frame
After the first 10 patients are completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) and the Mini International Neuropsychiatric Interview (M.I.N.I) 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Miron, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Intensive tDCS for MDD: Feasibility Study

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