Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression
Recruiting · NCT07212465 · Interventional (participants receive a specific treatment) · Lead sponsor: Rotman Research Institute at Baycrest
View the official record on ClinicalTrials.gov →Interventions studied
Active Brainsway H7-Coil Deep TMS SystemSham Brainsway H1-Coil Deep TMS System
What this trial is about
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 Depressive Disorder (MDD) who have not tolerated or responded to antidepressant medications. The study will evaluate whether accelerated dTMS administered over 5 consecutive days is safe and well-tolerated in this population, and whether it produces greater reductions in depressive symptoms compared to placebo stimulation.
Who can take part
Age range
60 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Rotman Research Institute at Baycrest - Toronto, Ontario, Canada