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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07050355
Status
Recruiting
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Conditions

  • Depression - Major Depressive Disorder
  • Stroke
  • Walking Impairment

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • rTMS — DEVICE
    Subjects will undergo rTMS to the left dorsolateral prefrontal region as a treatment for depression. Treatment will be performed three times per week for 12 weeks (36 sessions) . We will use a standard resting motor threshold (rMT) determination from unaffected abductor pollicis brevis. Treatments will be delivered at the EEG coordinate for F3 (approximating the left DLPFC) and will be found using the Beam-F3 method. A total of 5000 pulses/session will be delivered at 10Hz with an intensity of 120% of rMT.
  • AEx — BEHAVIORAL
    The goal of AEx will be 20 minutes of continuous walking at an intensity of \~70% of heart rate reserve (HRR calculated via the Karvonen method). The desired intensity will be achieved by a combination of increasing treadmill speed and incline. Rest breaks will be allowed as needed during training with the goal of progressing to 20 minutes of continuous walking.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Jun 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Severity of depressive symptoms [ Time Frame: baseline, after 2,4,6,8,10 and 12 weeks of treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University School of MedicineDurhamNorth Carolina27710-
Medical University of South CarolinaCharlestonSouth Carolina29425
Chris Gregory, PhD
[email protected]
843-792-1078
Catherine Vandewrwerker, PhD, PT
[email protected]

Find similar trials in Durham, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Duke University School of Medicine· Durham, NCMedical University of South Carolina· Charleston, SC

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