Actively Recruiting
Feasibility, Tolerability, and Preliminary Efficacy of Accelerated Deep Transcranial Magnetic Stimulation for Depression in Older Adults
Led by Rotman Research Institute at Baycrest · Updated on 2025-10-28
24
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol to reduce depressive symptoms in older adults aged 60 to 85 with Major Depressive Disorder (MDD) who have not responded well to or tolerated antidepressant medications. This study aims to assess the safety, tolerability, and preliminary efficacy of delivering multiple dTMS sessions per day over five consecutive days compared to a placebo stimulation. The trial is a single-site, double-blind, randomized sham-controlled design focusing on treatment-resistant depression in older adults. Participants will be randomly assigned to receive either active dTMS using the H7 coil or a sham intervention designed to mimic treatment sensations without brain stimulation. The active treatment involves 6 to 8 intermittent theta burst stimulation sessions daily at 80-90% of resting motor threshold over five days. The sham group will receive similar technical procedures without actual brain stimulation. This accelerated protocol seeks to determine feasibility and gather early evidence about the treatment's impact on depressive symptoms. During the study, participants will be monitored for attendance, comfort, adverse events, and withdrawal reasons over six weeks. Outcome measures include changes in depression rating scores one week after treatment, response and remission rates, brain activity changes measured by EEG, MRI, and MEG, as well as cognitive and emotional processing assessments up to one month following treatment. The trial will also evaluate heart rate variability and emotional task performance, ensuring comprehensive safety and efficacy monitoring throughout the participation period.
CONDITIONS
Brief Title
Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 60 and 85 years old on the day of randomization
- Diagnosed with DSM5 Major Depressive Disorder with current episode lasting more than 4 weeks but less than 5 years
- Did not respond to, did not tolerate, or failed to achieve remission with at least one antidepressant trial of minimum 8 weeks
- Willing to provide informed consent
- Able to follow the treatment schedule
- Stable on medications for at least 2 months with no expected changes during the study
- Satisfactory safety screening questionnaire for Transcranial Magnetic Stimulation (TMS)
You will not qualify if you...
- Have metal implants in the head such as ear implants, brain stimulators, or aneurysm clips (non-magnetic dental devices are allowed)
- Known or history of increased brain pressure that raises seizure risk
- Have a cardiac pacemaker
- Have an implanted medication pump
- Have a central venous line
- History of psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, PTSD, or dementia
- History of substance abuse in the last 6 months
- History of stroke or other brain lesions
- Personal or family history of epilepsy
- Pregnant or breastfeeding women
- History of abnormal brain MRI
- Untreated hypo- or hyper-thyroidism
- Unstable medical conditions
- Other contraindications to TMS
- On unstable doses of psychotropic medications
- Require daily benzodiazepines or hypnotics within two weeks of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive deep Transcranial Magnetic Stimulation (dTMS) or sham stimulation using an accelerated intermittent theta burst protocol targeting the anterior cingulate cortex. This involves 6 to 8 stimulation sessions per day for 5 consecutive days.
6 to 8 visits per day for 5 days (in-person)
Duration - Up to 6 weeks
Participants are monitored for treatment response, side effects, and changes in depression symptoms over the following weeks.
Periodic visits for assessments up to 6 weeks
Trial Site Locations
Total: 1 location
1
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada, M6A 2E1
Actively Recruiting
Research Team
A
Amanda Chao, MPH
L
Linda Mah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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