TEEN MENTAL HEALTH RESEARCH
rTMS Study

ABOUT THE STUDY

Transcranial magnetic stimulation (TMS) is a non-surgical procedure used in the treatment of adults with depression that has not responded to anti-depressant medication (treatment-resistant depression; TRD). TMS uses fluctuating magnetic fields to increase frontal lobe brain activity with the goal of reducing depression symptoms. It was approved by the U.S. Food & Drug Administration in 2008 to treat TRD in adults. Very little research has been done testing this intervention for treatment-resistant depression in young people. The purpose of this study is to measure the feasibility, tolerability, and efficacy of a 6-week course of repetitive TMS in adolescents with depression that has not improved after treatment with at least one antidepressant medication. We are also studying the neurobiological mechanisms and predictors of response to rTMS with Magnetic Resonance Imaging (MRI).

 

ELIGIBILITY

INCLUSION CRITERIA:
  • Between 12-18 years old
  • Diagnosis of Major Depressive Disorder (MDD)
  • Experiencing a current MDD episode with a duration of ≥ 4 weeks and ≤3 years
  • Resistance to treatment (i.e. failure to respond to at least 1 antidepressant treatment
  • Both child and parent/guardian are English speaking
  • Female participants who are sexually active during the course of the study must use a form of birth control for the duration of the study
EXCLUSION CRITERIA:
  • A clinically defined neurological disorder or insult
  • Any subject with an increased risk of seizure
  • TMS or MRI contraindications
  • Any subject with implanted devices or implanted metals in their body
  • Inability of staff to locate and quantify a motor threshold
  • Inability to tolerate stimulation at 120% of motor threshold after 2 weeks of titration
  • History of treatment with ECT or TMS therapy for any disorders
  • Participation in any investigational drug trial within 4 weeks of the baseline visit
  • Pregnancy
  • IQ < 80
  • Clinically significant laboratory abnormality of medical condition
  • Suicide attempt within the previous 6 months that required medical treatment or ≥2 attempts in the past 12 months or active suicidal risk
  • Therapy changes in past 3 months
  • Medication changes in past 6 weeks
  • A diagnosis of substance use disorder, Schizophrenia, Bipolar Disorder, or Autism
  • Current treatment with Bupropion at a dose greater than 150mg/day
  • Current treatment with a stimulant medication as an adjunct medication for depression
  • Current treatment with a stimulant medication for ADHD above FDA recommended dosages

STUDY ACTIVITIES

​INTERVIEW & CLINICAL ASSESSMENT:
​For the first visit, you will be asked to come to the Ambulatory Research Center (ARC) at the Fairview Riverside Hospital for an interview. We will ask you about your medical history and your symptoms. Participants under the age of 18 will also be asked to have a parent/guardian attend and participate in a separate interview. The participant and parent/guardian (if applicable) will also complete a number of questionnaires. The participant will also complete some paper and pencil tasks and computer assessments. This appointment will take 3-4 hours as we do a very thorough assessment.

​MAGNETIC RESONANCE IMAGING (MRI) VISITS:
Both before and after the 6 weeks of rTMS sessions, you will be asked to come to the Center for Magnetic Resonance Research (CMRR) for a brain scan. You will be asked to lie in the scanner while the machine takes pictures of your brain. While you are in the scanner, you will be doing things like listening to music, resting, and doing a task that involves looking at faces with words printed over them and assessing whether the word is positive or negative. These visits will take 2 hours each.

rTMS SESSIONS:
The study stimulation procedure is given 5 days a week for 6 weeks at the MINCEP Epilepsy Clinic in St. Louis Park. The session itself lasts about 20 minutes each time; the visits will usually be about 30 minutes but once a week the visits will be longer to allow time for additional assessments.  A trained technician places a cap on your head and then a helmet over the cap. The coil in the helmet sends magnetic pulses to activate certain parts of the brain. At the first session, a study doctor takes some measurements, determine the best place for stimulation. 

WEEKLY CHECK-IN VISITS:
One day a week, you will have a slightly longer appointment where a member of the research team will meet with you to complete some questionnaires and ask you how things are going. They will also take more measurements.

POST rTMS ASSESSMENT:
After you have completed the rTMS sessions, you will be asked to come back to the Ambulatory Research Center to meet with the researchers again. They will go over some questionnaires with you and have you complete the computer and paper tasks you completed at the first assessment again. At the end of this visit, they will tell you which group you were randomized into and whether or not you responded to the rTMS sessions.

FOLLOW-UP VISITS:
After you have completed all of the rTMS sessions you will be asked to come back to the Ambulatory Research Center (ARC) once a month for 6 months to complete follow-up visits with the research team. At these visits, the research team will check in with you about your depression and how you've been doing since the last visit.

COMPENSATION

​​You will be compensated for some of the visits in the study. You will receive a total of $220 if you complete all portions of the study. If you only complete some portions of the study, you will be compensated for each portion you do complete. Parking costs will be reimbursed.