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Neuromodulation for Exercise Adherence

Phase 4
Recruiting
Led By Kalpana P Padala, MD MS
Research Sponsored by VA Office of Research and Development
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 14 weeks, 16 weeks, 40 weeks
Awards & highlights

Study Summary

This trial will study whether magnetic brain stimulation can improve older Veterans' adherence to an at-home excercise program, which in turn could improve their balance and prevent falls.

Who is the study for?
This trial is for sedentary Veterans aged 60+ who spend a lot of time sitting daily and have a TV at home. It's not for those who are already physically active, use wheelchairs, have significant cognitive impairments, weigh over 325 lbs., or have health conditions that make exercise unsafe. People taking certain medications or with a history of seizures, stroke, bipolar disorder, or abnormal EEGs can't join.Check my eligibility
What is being tested?
The study tests if magnetic brain stimulation (rTMS) paired with Nintendo Wii-Fit exercises improves exercise adherence in older adults with executive dysfunction. Participants will train on the Wii-Fit and then receive either real rTMS or sham treatment based on their initial exercise habits and brain function.See study design
What are the potential side effects?
Real rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Sham treatment has no expected side effects but does not provide any therapeutic benefit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks, 16 weeks, 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks, 16 weeks, 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adherence as measured by number of minutes
Change in Adherence as measured by number of sessions
Change in Conner's Continuous Performance Test
Secondary outcome measures
Change in Gait speed
Change in Timed Up and Go

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: No interventionExperimental Treatment1 Intervention
This group will receive no intervention
Group II: rTMSActive Control1 Intervention
This group will be randomized to receive rTMS
Group III: ShamPlacebo Group1 Intervention
This group will be randomized to receive sham treatment

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,607 Previous Clinical Trials
3,305,929 Total Patients Enrolled
Kalpana P Padala, MD MSPrincipal InvestigatorCentral Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Media Library

No intervention Clinical Trial Eligibility Overview. Trial Name: NCT03733041 — Phase 4
Poor Exercise Compliance Research Study Groups: No intervention, rTMS, Sham
Poor Exercise Compliance Clinical Trial 2023: No intervention Highlights & Side Effects. Trial Name: NCT03733041 — Phase 4
No intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03733041 — Phase 4

Frequently Asked Questions

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

Are there risks associated with using repetitive transcranial magnetic stimulation?

"The safety of rTMS has been substantiated, so it receives a ranking of 3 on our scale. This is due to its acceptance as a clinically approved treatment modality."

Answered by AI

What is the current capacity for participants in this investigation?

"Affirmative. The research hosted on clinicaltrials.gov indicates that the trial is currently recruiting participants, with a first posting date of April 1st 2019 and most recently updated information from April 4th 2022. This medical experiment requires 106 individuals to be enrolled at one site."

Answered by AI

Are there still openings for participation in this experiment?

"Per information available on clinicaltrials.gov, this trial is actively enlisting participants as of April 4th 2022. This research study was initially posted on the 1st of April 2019."

Answered by AI
~15 spots leftby Jan 2025