Status:
RECRUITING
Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression
Lead Sponsor:
Rotman Research Institute at Baycrest
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test whether an accelerated deep Transcranial Magnetic Stimulation (dTMS) protocol can reduce depressive symptoms in older adults (ages 60-85) with Major Depressi...
Detailed Description
This study will investigate the effects of an accelerated intermittent theta burst protocol (a-iTBS) using the H7 deep Transcranial Magnetic Stimulation (dTMS) coil to target the anterior cingulate co...
Eligibility Criteria
Inclusion
- are between 60- 85 years old (on the day of randomization)
- have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer 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 8 week minimum duration
- are willing to provide informed consent
- are able to follow the treatment schedule
- are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
- have a satisfactory safety screening questionnaire for TMS
Exclusion
- have a metal plate in your head (such as an ear implant, implanted brain stimulators, aneurysm clips). Dental devices and implants that are non-magnetic are safe
- have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
- have a cardiac pacemaker
- have an implanted medication pump
- have a central venous line
- have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia
- have a history of substance abuse in the last 6 months
- have a history of stroke or other brain lesions
- have a personal history of epilepsy
- have a family history of epilepsy
- are a pregnant or breast-feeding woman
- have a history of abnormal MRI of the brain
- have untreated hypo- or hyper-thyroidism
- have unstable medical condition(s)
- have any other known contraindications to TMS
- are on unstable doses of any psychotropic medication such as - antidepressants, antipsychotic, mood stabilizers or memory enhancing medications
- require daily doses of benzodiazepines or hypnotics within two weeks of randomization
Key Trial Info
Start Date :
July 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07212465
Start Date
July 21 2025
End Date
February 15 2027
Last Update
October 28 2025
Active Locations (1)
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1
Rotman Research Institute at Baycrest
Toronto, Ontario, Canada, M6A 2E1