← Back to Search

tDCS + Mindfulness Meditation for Depression (START Trial)

N/A
Waitlist Available
Led By Daniel Blumberger, MD, MSc
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of Major Depressive Disorder with most recent depressive episode treated with acute rTMS
Age 18-85, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

START Trial Summary

This trial will study whether a combination of transcranial direct current stimulation (tDCS) and mindfulness meditation can help people maintain wellness after an acute course of repetitive transcranial magnetic stimulation (rTMS).

Who is the study for?
This trial is for adults aged 18-85 who have major depressive disorder, responded well to rTMS treatment, and can consent to participate. Excluded are those with unstable illnesses, certain psychiatric disorders like psychosis or PTSD within the last year, significant cognitive impairments, high doses of benzodiazepines or anticonvulsants, recent substance abuse, neurological disorders, or scalp conditions affecting tDCS.Check my eligibility
What is being tested?
The study tests if active tDCS combined with mindfulness meditation helps maintain wellness after rTMS treatment for depression compared to a sham (fake) tDCS. It's a double-blind RCT where neither participants nor researchers know who receives real or sham treatment until the end of the study.See study design
What are the potential side effects?
tDCS may cause mild side effects such as itching, tingling at the electrode sites on the scalp during application; headache; fatigue; nausea; and insomnia. Mindfulness meditation is generally considered safe but may sometimes bring up emotional discomfort.

START Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been treated for depression with rTMS.
Select...
I am between 18 and 85 years old.

START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients maintaining remission of depressive symptoms or response to rTMS treatments as measured by the Hamilton Rating Scale for Depression - 17 Hamilton Rating Scale for Depression (17-item version)
Secondary outcome measures
Proportion of responders and remitters who relapse

START Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: active tDCS + mindfulness meditationExperimental Treatment1 Intervention
Participants randomized to this group will receive active tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.
Group II: sham tDCS + mindfulness meditationPlacebo Group1 Intervention
Participants randomized to this group will receive sham tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tDCS + mindfulness meditation
2018
N/A
~70

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,376 Total Patients Enrolled
86 Trials studying Depression
19,251 Patients Enrolled for Depression
University Health Network, TorontoOTHER
1,472 Previous Clinical Trials
484,925 Total Patients Enrolled
54 Trials studying Depression
12,150 Patients Enrolled for Depression
Daniel Blumberger, MD, MScPrincipal InvestigatorCentre for Addiction and Mental Health
4 Previous Clinical Trials
835 Total Patients Enrolled
4 Trials studying Depression
835 Patients Enrolled for Depression

Media Library

active tDCS + mindfulness meditation Clinical Trial Eligibility Overview. Trial Name: NCT03708159 — N/A
Depression Research Study Groups: active tDCS + mindfulness meditation, sham tDCS + mindfulness meditation
Depression Clinical Trial 2023: active tDCS + mindfulness meditation Highlights & Side Effects. Trial Name: NCT03708159 — N/A
active tDCS + mindfulness meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03708159 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research currently enrolling new participants?

"This clinical trial, which began recruiting on September 24th 2018, is still actively searching for participants according to information found on clinicaltrials.gov. The most recent update was March 4th 2022."

Answered by AI

What is the maximum capacity of participants for this clinical trial?

"Correct. According to clinicaltrials.gov, this trial is currently searching for 200 participants across 2 locations and was first posted on September 24th 2018 before being updated lastly on March 4th 2022."

Answered by AI

Do you have an age limit for enrolment into this trial?

"The eligibility rules for this clinical trial necessitate that patients are aged 18-85. There is a wealth of research available to individuals beneath the age of 18, as well as 596 studies directed at those over 65."

Answered by AI

What criteria must be met in order to take part in this medical experiment?

"This medical trial is seeking two-hundred individuals aged 18 to 85 who have been diagnosed with major depressive disorder (MDD). Eligibility criteria include the capacity for consent, prior outpatient/research participant status and remission or response demonstrated through a 50% improvement on any depression scale since treatment initiation. Patients must also present an HRSD-17 score of less than 15, or 8 at minimum."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Maintenance of Response After rTMS for Depression Using tDCS
Daniel Blumberger 2018. "Maintenance of Response After rTMS for Depression Using tDCS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03708159.
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top