Patient-Oriented Randomized Pragmatic Feasibility Trial: rTMS Depression Study
Background
Major Depressive Disorder (MDD) is a very common medical condition that can have many causes, such as life experiences, genetics, and changes in the way the body and brain function. MDD is often treated with antidepressant medication, however, 30-40% of patients do not respond to their first medication treatment. We are doing this study evaluate whether a definitive adaptive pragmatic trial would be feasible by mimicking the real-world use of rTMS in a clinical setting (e.g., recruiting participants with less strict inclusion and exclusion criteria).
Repetitive Transcranial Magnetic Stimulation (rTMS) is a treatment that involves stimulating certain areas of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of depression. The device used in this study has been approved by Health Canada for therapeutic use since 2002.
Details
This study will take up to approximately 9 weeks to complete. Participants deemed eligible after completing the screening visit virtually through a secured teleconferencing platform (i.e., UBC Zoom) will be asked to come to UBC for a baseline visit, where they will complete some questionnaires and assessments. After the baseline visit, participants will complete 6-9 weeks of either iTBS rTMS on the left dorsolateral prefrontal cortex (L-DLPFC) OR 1Hz rTMS treatments to the right dorsolateral prefrontal cortex (R-DLPFC). Participants will have questionnaires and assessments every fifth treatment day throughout the treatment course. Within a week of completing the rTMS treatment course, they will be asked to repeat the baseline measures. All visits that do not require in-person measurements (e.g., screening and follow-up interviews) would be conducted remotely via a secured teleconferencing platform (i.e., UBC Zoom).
Treatment Schedule
Treatment will take place every weekday for 6-9 weeks. Each treatment session will last for approximately 30 minutes.
The Team
The study is being conducted researchers The University of British Columbia. The principal investigator is Dr. Fidel Vila-Rodriguez, director of the NINET lab at the UBC Hospital. The co-principal investigator is Lisa Ridgway, a patient-partner. See more about our team here.
You may be eligible to participate if…
- You are at least 18 years of age
- You have depression or bipolar depression
- You have had no increase or initiation of any psychotropic medication in the last 4 weeks
- You are able to adhere to the treatment schedule
If you are considering participating in the PORT trial, please inform us…
- If you are pregnant, or thinking of becoming pregnant
- All medications that you are taking, including herbal supplements and over the counter medication.
- If possible, bring a list of medications to your first study visit, including how often you take them and the dosages.
- If you have a history of seizures and/or family history of seizures
- If you have had any past injuries or surgeries, or other physical or mental health problems.
- If you have:
- Aneurysm clips or coils
- Stents in the neck or brain
- Implanted stimulators (e.g., cardiac pacemakers, implantable cardioverter defibrillator (ICD))
- Metallic implants in your ears or eyes (e.g., dental implants, cochlear implants)
- Hearing Aid
- Shrapnel or bullet fragments in or near the head
- Facial tattoos with metallic or magnetic-sensitive ink
- Other metal devices or object implanted in or near the head
Interested? For more details regarding the study or to discuss enrolment, please contact us at (604)-822-7308 or email ninet.lab@ubc.ca
Frequently Asked Questions
Your confidentiality will be respected. No information or records that disclose your identity will be published without consent, nor will any of your information or records that disclose your identity be removed or released without your consent, unless required by law.
Nothing! TMS treatments can cost up to $250 per session, however, when participating in a research study, you will receive treatment for free.
You may find that your symptoms improve, however this is not guaranteed. Information gathered from this study may help other people undergoing TMS or medication treatments for mood disorders in the future. In general, we hope that the information learnt from this study can be used in the future to benefit other people with depression and related disorders.