Autonomic Effects of Stimulation in SCI

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT05664646
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DS8R — DEVICE
    transcutaneous stimulation of the spinal cord.
  • Arm Ergometry — OTHER
    Study 1 will use the arm ergometry as a form of exercise.
  • Cool Environment — OTHER
    Study 2 will be completed in a cool environment setting.

Study Details

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

Key Dates

Start date
Jul 24, 2023
Status verified
Jul 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Without stimulation
    For study 1, exercise power output and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.
  • Active Comparator: With stimulation
    For study 1, exercise power output and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.

Primary Outcome Measure

Power Output [ Time Frame: through study completion, up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Jill Wecht, EdD
[email protected]
718-584-9000
Matthew T Maher, MS
[email protected]
(718) 584-9000
Jill Wecht, EdD (PRINCIPAL_INVESTIGATOR)

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By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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