Autonomic Effects of Stimulation in SCI

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury
• Interventions: Other: Arm Ergometry; Device: DS8R; Other: Cool Environment

• Registration Number: NCT05664646
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time 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.

Detailed Description

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time 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. The study will consist of 7 visits, that will be between 3-4 hours in duration, separated by no less than 3 days. Visit 1 will consist of determining baseline autonomic function and screening visit. The participant will undergo a sit up set to determine hypotension and orthostatic hypotension and complete a couple surveys. Visits 2 and 3 will determine which site the stimulation parameters should be on the spine, either T7-T8 or T11-12. The site that increases seated systolic blood pressure will be used for the rest of the study. Visits 4 and 5 will consists of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-27
• Study Start: 2023-07-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• injury more than 1 year ago, non-ambulatory
• level of lesion C3-T1, AIS A or B
• stable prescription medication regimen for at least 30 days
• must be able to commit to study requirements of 7 visits within a 60-day period

Exclusion Criteria

• extensive history of seizures
• ventilator dependence or patent tracheostomy site
• history of neurologic disorder other than SCI
• history of moderate or severe head trauma
• contraindications to spine stimulation
• significant cardiovascular disease
• active psychological disorder
• recent history (within 3 months) of substance abuse
• open skin lesions over spine at levels targeted for stimulation (T7/8, T11/12) and pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Without stimulation	Arm Ergometry	For study 1, exercise endurance time 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.
With stimulation	Cool Environment	For study 1, exercise endurance time 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.
Without stimulation	Cool Environment	For study 1, exercise endurance time 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.
With stimulation	Arm Ergometry	For study 1, exercise endurance time 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.
With stimulation	DS8R	For study 1, exercise endurance time 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 Measures

Name	Time	Method
Amplitude of TSCS	through study completion, up to 2 years	Amplitude of the stimulation will start at 5mA and increase in increments of 5mA to determine the best amplitude to normalize blood pressure. The same spinous process sites (T7/T8, T11/12) will be used. The best amplitude will be used to increase blood pressure during Study 1 (arm ergometry) and Study 2 (cool environment).
Electrode placement	through study completion, up to 2 years	Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T11/12). Determine the best electrode placement on the spine that increases blood pressure to around 120/80 mmHg in the seated position.

Secondary Outcome Measures

Name	Time	Method
Heart Rate Recovery Time	through study completion, up to 2 years	Determine if TSCS shortens the amount of time for HR recovery (return to baseline) compared to no stimulation.
Body Core Temperature	through study completion, up to 2 years	Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.
Exercise Endurance Time	through study completion, up to 2 years	Determine if TSCS increases exercise endurance time compared to no stimulation.
Subjective Reporting on Thermal Comfort and Thermal Sensation	through study completion, up to 2 years	To determine if TSCS helps improve subjective reporting on thermal comfort and thermal sensation compared to no stimulation.

Trial Locations

Locations (1)

James J. Peters VA Medical Center, Bronx, NY; 🇺🇸 Bronx, New York, United States