Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Investigators primary aim is to carry out a two-site, randomized, double-blind, sham-controlled, phase II trial to systematically examine the potential for aerobic exercise (AEx) to enhance the anti-depressant benefits of rTMS in individuals with post-stroke depression (PSD). Investigators propose to determine the efficacy of combining two known anti-depressant treatments shown to be effective in non-stroke depression, aerobic exercise (AEx) and repetitive transcranial magnetic stimulation (rTMS), on post-stroke depressive symptoms. This project is based on the idea that depression negatively affects the potential for the brain to adapt in response to treatment such that rehabilitation may not produce the same changes that it does in non-depressed individuals. Investigators believe that effective treatment for PSD will result in a virtuous cycle whereby reducing depression enhances response to rehabilitation, thereby facilitating functional gains. That is, effectively treating depression will enable individuals to better recover from stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• age 21-70

• stroke within the past 12 to 60 months

• screen positive for probable major depressive disorder (PHQ-9 \> 10) and HAM-D17 ≥ 14

• residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)

• ability to walk without assistance and without an AFO at speeds ranging from 0.2-1.0 m/s

• not currently on antidepressant medications or no changes in antidepressant dosage in the last 4 weeks and clinically stable

• HAM-D17 question #9 regarding suicide \<2

• provision of informed consent.

Locations
United States
North Carolina
Duke University School of Medicine
ACTIVE_NOT_RECRUITING
Durham
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Chris Gregory, PhD
gregoryc@musc.edu
(843)792-1078
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 96
Treatments
Active_comparator: rTMS
repetitive transcranial magnetic stimulation
Active_comparator: AEx
treadmill aerobic exercise
Experimental: rTMS + AEx
combination of repetitive transcranial magnetic stimulation and treadmill aerobic exercise
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: National Institutes of Health (NIH), Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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