Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
NCT ID: NCT05960448
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-07-30
2026-07-30
Brief Summary
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* 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.
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Detailed Description
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The purpose of part two of this study is to compare the effects of electricity being delivered through surface electrodes (sticky pads on the participants skin), called active transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with electricity initially turned on but then turned off) on the participants ability to 1) keep the participants body temperature stable and 2) feel comfortable, while in a cool environment (cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot and their comfort level by asking the participant to grade their thermal comfort (how comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral room (80° F) and again in the cool room with active TSCS compared to the cool room with sham TSCS. The results will help guide experimental studies aimed at improving health and longevity in the population with SCI. If the participant chooses to participate in this study, there will be 2 study visits that last about 3-4 hours each.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
Transcutaneous Spinal Cord Stimulation (TSCS)
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
The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
Sham Transcutaneous Spinal Cord Stimulation
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Interventions
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Transcutaneous Spinal Cord Stimulation (TSCS)
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
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* You have an SCI between C3-T6
* You have been injured longer than 1 year
* You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
* You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
* Your prescription medications have not changed for at least 30 days
Exclusion Criteria
* You have an acute illness or infection
* You have diabetes
* You have untreated thyroid disease
* You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
* You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)
* You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment
* You have a present or history of a psychological disorder
* You have contraindications to electricity over your spine
* You are dependent on a ventilator to breathe or have an open tracheostomy site
* You have a recent history of substance abuse (within the past 3 months)
* You have open wounds over the spine at the level targeted for stimulation
* You are pregnant
18 Years
ALL
No
Sponsors
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James J. Peters Veterans Affairs Medical Center
FED
Responsible Party
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Jill M. Wecht, Ed.D.
Principal Investigator
Principal Investigators
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Jill M Wecht, EdD
Role: PRINCIPAL_INVESTIGATOR
James J. Peters Veterans Affairs Medical Center
Locations
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James J Peters VAMC
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1727500
Identifier Type: -
Identifier Source: org_study_id
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