Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
October 1, 2024
September 1, 2024
3 years
July 17, 2023
September 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Exercise Endurance Time
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
During procedures (30 minutes)
Recovery Heart Rate
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
During procedures (60 minutes)
Tcore
This outcome measure is measured in degrees Celsius.
During procedures (90 minutes)
Thermal Comfort
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
During procedures (90 minutes)
Secondary Outcomes (2)
Workload
End of exercise (30 minutes)
Rate of Perceived Exhaustion
End of exercise (30 minutes)
Study Arms (2)
Transcutaneous Spinal Cord Stimulation
EXPERIMENTALThe 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 Transcutaneous Spinal Cord Stimulation
SHAM COMPARATORThe sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
Interventions
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.
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Eligibility Criteria
You may qualify if:
- You are above the age of 18 years old
- 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
You may not qualify if:
- You have a history of seizures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James J Peters VAMC
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill M Wecht, EdD
James J. Peters Veterans Affairs Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant will not know whether or not they are receiving spinal stimulation at any given session
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 25, 2023
Study Start
July 30, 2023
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share