Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

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

Sponsor
James J. Peters Veterans Affairs Medical Center
Study ID
NCT05960448
Status
Recruiting
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Conditions

  • Orthostatic Hypotension

Eligibility Criteria

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

Interventions

  • Transcutaneous Spinal Cord Stimulation (TSCS) — OTHER
    This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit.
  • Sham Transcutaneous Spinal Cord Stimulation — OTHER
    This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.

Study Details

The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.

Key Dates

Start date
Jul 30, 2023
Status verified
Sep 2024
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

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

Arms

  • Experimental: Transcutaneous Spinal Cord Stimulation
    The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.
  • Sham Comparator: Sham Transcutaneous Spinal Cord Stimulation
    The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.

Primary Outcome Measure

Exercise Endurance Time [ Time Frame: During procedures (30 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J Peters VAMCThe BronxNew York10468
Matthew T Maher, MS
[email protected]
718-584-9000
Jill M Wecht, EdD (PRINCIPAL_INVESTIGATOR)

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James J Peters VAMC· The Bronx, NY

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