RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07050355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 21-70
  2. * stroke within the past 12 to 60 months
  3. * screen positive for probable major depressive disorder (PHQ-9 \> 10) and HAM-D17 ≥ 14
  4. * residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
  5. * ability to walk without assistance and without an AFO at speeds ranging from 0.2-1.0 m/s
  6. * not currently on antidepressant medications or no changes in antidepressant dosage in the last 4 weeks and clinically stable
  7. * HAM-D17 question #9 regarding suicide \<2
  8. * provision of informed consent.
  1. * unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
  2. * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  3. * history of COPD or oxygen dependence
  4. * history of traumatic brain injury
  5. * blindness or severe visual impairment
  6. * history of psychosis or other Axis I disorder that is primary
  7. * life expectancy \<1 yr.
  8. * severe arthritis or problems that limit participation in testing or training
  9. * history of DVT or pulmonary embolism within 6 months
  10. * uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  11. * severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
  12. * attempt of suicide in the last 2 years or suicidal risk assessed by SCID
  13. * history of seizures or currently prescribed anti-seizure medications
  14. * current enrollment in a trial to enhance motor recovery
  15. * currently participating in behavioral treatment for depression
  16. * currently exercising ≥ 2 times per week (≥20 minutes)
  17. * contraindications to TMS
  18. * pregnancy or other contraindications to MRI.

Contacts and Locations

Study Contact

Chris Gregory, PhD
CONTACT
(843)792-1078
gregoryc@musc.edu

Study Locations (Sites)

Duke University School of Medicine
Durham, North Carolina, 27710
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

  • stroke
  • rehabilitation
  • neuromodulation
  • TMS
  • walking
  • exercise

Additional Relevant MeSH Terms

  • Stroke
  • Depression - Major Depressive Disorder
  • Walking Impairment