LeRNIT Trial

Left vs. Right Non-Inferiority 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. 

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.  

This study will investigate the aforementioned brain stimulation device procedure, repetitive transcranial magnetic stimulation (rTMS), which has been shown to be helpful in treating some psychiatric and neurological disorders. In this study, we aim to compare two different rTMS protocols, which are low-frequency rTMS (LFR) to the right dorsolateral prefrontal cortex (R-DLPFC), and the intermittent theta burst stimulation (iTBS) to the left dorsolateral prefrontal cortex (L-DLPFC). 

Details

This study will take up to 20 weeks to complete. If you are deemed eligible after completing the screening visit, you will be asked to come to UBC for a baseline visit, where you will complete some questionnaires and assessments and a brain scan. After the baseline visit, you will be randomized to either receive LFR protocol to the right DLPFC, or iTBS protocol to the left DLPC. Following this, you will complete 6 weeks of rTMS treatments using either protocol. You will have questionnaires and assessments every couple of days throughout the treatment course. Following the rTMS treatment course, you will be asked to repeat the baseline measures. There will also be three follow-up visits: 1 week, 4 weeks, and 12-weeks post-treatment completion. These will include questionnaires and clinical interviews. All visits that do not require in-person measurements (e.g., screening and follow-up interviews) may be conducted remotely via a secured teleconferencing platform (i.e., UBC Zoom). 

Treatment Schedule

Treatment will take place every weekday for 6 weeks. Each treatment session will last for approximately 15 minutes. 

The Team

The study is being conducted by researchers at The University of British Columbia, as well as at the Centre for Addiction and Mental Health (CAMH) in Toronto. The principal investigator is Dr. Fidel Vila-Rodriguez, director of the NINET lab atthe UBC Hospital. See more of our team here.

You may be eligible to participate if…

• You have a diagnosis of Major Depressive Disorder (MDD)
• You have failed to respond to at least 1 antidepressant medication
• You are between 18-65 years old
• You are able to adhere to the treatment schedule

If you are considering participating in the LeRNIT 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 a 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 stimulations (e.g., cardiac pacemakers, implantable cardioverter defibrillator; ICD)
  • Metallic implants in 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

Frequently Asked Questions