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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Intervention
Intervention Acceptability
Secondary outcome measures
Resting state motor thresholds
short-interval intracortical facilitation (SICF)
short-interval intracortical inhibition (SICI)

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
~1310
Video Watching
2013
N/A
~50

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,388 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
247,082 Total Patients Enrolled

Media Library

Aerobic Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05913401 — N/A
Major Depressive Disorder Research Study Groups: Aerobic Exercise, Video Condition
Major Depressive Disorder Clinical Trial 2023: Aerobic Exercise Highlights & Side Effects. Trial Name: NCT05913401 — N/A
Aerobic Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05913401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research currently accepting participants?

"Based on the data hosted by clinicaltrials.gov, this particular trial is not actively seeking new participants. It was initially posted in September 1st 2023 and last updated June 12th of the same year. However, there are presently 1344 medical studies which remain open for recruitment."

Answered by AI

Who else is applying?

What site did they apply to?
Butler Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I've tried self help groups without much result.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Exercise to Augment TMS in Those With Treatment Resistant Depression
2024. "Exercise to Augment TMS in Those With Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05913401.
All > Depression Boston
~20 spots leftby Aug 2024
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