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Exercise + TMS for Treatment Resistant Depression

N/A

Recruiting

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out if combining aerobic exercises with rTMS can improve outcomes for people with depression. Positive findings would create a safe and feasible way to treat this public health issue.

Who is the study for?

This trial is for adults over 18 with treatment-resistant depression who are approved for standard TMS therapy at Butler Hospital's clinic and can safely do moderate-intensity exercise.

What is being tested?

The study tests if doing aerobic exercise before receiving repetitive Transcranial Magnetic Stimulation (rTMS) improves outcomes in treating major depressive disorder compared to just watching videos.

What are the potential side effects?

While the trial primarily involves exercise, potential side effects may include typical risks associated with physical activity such as muscle strain or injury. rTMS may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of Intervention

Intervention Acceptability

Secondary study objectives

Resting state motor thresholds

short-interval intracortical facilitation (SICF)

short-interval intracortical inhibition (SICI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Video ConditionExperimental Treatment1 Intervention

In this condition, participants will be asked to sit and watch various documentaries or educational videos on topics NOT related to physical activity. These will last approximately 20 minutes and will occur before each TMS session.

Group II: Aerobic ExerciseExperimental Treatment1 Intervention

Exercise sessions will be 20 minutes of moderate-intensity aerobic exercise on a treadmill. A treadmill is located on D1A within the space shared by the Butler Hospital TMS Clinic and the COBRE-support Neuromodulation Research Facility. A research staff member will monitor their heart rate and blood pressure to ensure safety and that activity is occurring at a moderate intensity (i.e., 64-76% of age predicted maximal heart rate). Participants will be asked to rate their affect and rating of perceived exertion (RPE) during exercise sessions. Sessions will include a 5-min warm-up and a 5-min cool-down to ensure safe exercise procedures. Participants will be asked to answer questions about affect before, during, and after exercise. These sessions will be supervised (i.e., they provide onsite coverage) by an exercise physiologist or medical staff member (e.g., nurse or physician) to ensure safety.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Exercise

2013

Completed Early Phase 1

~1350

Video Watching

2013

N/A

~50