NIFtY Trial

Neuromodulation in Female Youth Trial: TBS Depression Study

Background

Major Depressive Disorder (MDD) affects approximately 1 in 4 people at any given point in time and impacts nearly every facet of life through a variety of symptoms. In its extreme, MDD can lead to suicidality, which is one of the leading causes of death among those between the ages of 10 and 34. In particular, adolescence and young adulthood are periods marked by social and biological challenges that often precede first instances of depression and are more likely to continue into later life. 

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 and is officially recommended by the Health Technology Assessment Committee of British Columbia to be publicly provided for treatment-resistant depression, as of 2022.  

However, rTMS treatments are considered costly in time and accessibility on behalf of patients requiring daily treatments lasting ~37.5 minutes each – often on the order of weeks. Intermittent theta burst stimulation (TBS) is an accelerated treatment that uses high-frequency bursts of activity with shorter, 3 minute sessions. This accelerated treatment has been shown to be non-inferior to the lengthier rTMS protocols (which means it has been shown to not produce worse results). However, these treatments have yet to be implemented in youth. Moreover, while there has been evidence that both MDD and rTMS outcomes are affected by hormonal factors, there has yet to be a study that looks at these issues directly.  

Objective

The goal of this study is to determine if this protocol (TBS treatment alongside menstrual cycle tracking) is acceptable, tolerable, and has realistic participant compliance among a sample of female youth before moving forward with larger clinical trials. 

Details

This study will take up to 13 months to complete. if you are deemed eligible after completing the screening visit, you will begin to receive daily surveys via email to track menstruation. You will also be asked to come to UBC for a baseline visit. There, you will complete some questionnaires and assessments, as well as two brain scans. 

This study is divided into three phases: the accelerated phase, the “top-up” phase, and the follow-up phase.

Following the baseline visit, you will be scheduled to begin the first accelerated phase of treatment as soon as possible after you begin menstruation (i.e., have your period) that month. You will receive a total of 20 treatments divided among 5 daily sessions. You will then transition to the top-up phase, where you have one treatment session where you will receive 4 treatments at each session once a week for three weeks (8 sessions/days, for a total of 32 treatments). You will also 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. During the follow-up phase there are no treatments. You are only required to alert the research team, via email, the start and end of your period for each month until you complete the study. There will also be five follow-up visits: 1 week, 3 months, 6 months, 9 months, and 12 months post-treatment completion. These will include questionnaires, clinical interviews, and some brain scans.

Treatment Schedule

Accelerated phase: One TBS treatment visit per day for 5 consecutive days.

Top-up phase: One TBS treatment visit per week for 3 weeks.

Each treatment visit lasts approximately 3.5 hours (including brief surveys) and consists of four 3-minute TBS treatment sessions, with a 30-minute break between each session. Some visits also include additional demographic and clinical questionnaires (lasting ~ 1 hour).

The Team

The study is being conducted by researchers at The University of British Columbia. The principal investigator is Dr. Fidel Vila-Rodriguez, director of the NINET lab at the UBC Hospital. See more of our team here.

You may be eligible to participate if…

• You were assigned female sex at birth (AFAB), regardless of current gender identity 
• You have a diagnosis of moderate or severe major depressive episode (MDE)
• You are between 16-24 years old
• You are able to adhere to the treatment schedule

If you are considering participating in the NIFtY 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