Exploring brain activity changes in depression treatment with rTMS
Quantitative Electroencephalography to Longitudinally Assess the Functional Brain Signature of Treatment-resistant Depression and Recovery With Therapeutic Neuromodulation
PHASE1 · Sunnybrook Health Sciences Centre · NCT06719427
This study is testing how a treatment called rTMS changes brain activity in people with major depression to see if it can help improve their mood and reduce the chance of relapse.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 2 sites (North York, Ontario and 1 other locations) |
| Trial ID | NCT06719427 on ClinicalTrials.gov |
What this trial studies
This study investigates how repetitive transcranial magnetic stimulation (rTMS) affects brain function in patients with major depressive disorder. Using dry quantitative EEG (qEEG), researchers will measure brain electrical activity before, during, and after rTMS treatment to identify patterns associated with symptom improvement and relapse risk. The study aims to personalize depression treatments by correlating brain activity changes with clinical outcomes, focusing on the dorsolateral prefrontal cortex, a key region in mood regulation. Participants will undergo an accelerated rTMS protocol over five days, with mood evaluations and qEEG recordings conducted at multiple time points.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of major depressive disorder who are receiving rTMS treatment.
Not a fit: Patients with significant comorbid psychiatric disorders, seizure history, or severe substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatments for patients with treatment-resistant depression.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques like rTMS for depression, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of Depression based on Diagnostic and Statistical Manual (DSM) 5.0 criteria. * Receiving a neuromodulation (rTMS) treatment for depression at the HCN * Physically healthy * Age 18-80, inclusive. * Able to provide informed consent and comply with the study protocol. * Patients will not be excluded solely based on communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties. Exclusion Criteria: * Moderate substance use disorder or greater severity based on DSM 5.0 criteria and confirmed by a study MD on clinical assessment. * Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy) * A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment. * History of seizure disorder * Pregnant
Where this trial is running
North York, Ontario and 1 other locations
- Sunnybrook Health Sciences Centre — North York, Ontario, Canada (NOT_YET_RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Sean M Nestor, M.D.
- Email: sean.nestor@utoronto.ca
- Phone: 416-347-0257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Diorder, Transcranial Magnetic Stimulation, Treatment-resistant Depression, Mood Disorders, Mental Disorders, Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant