Autonomic Effects of Stimulation in SCI

Spinal Cord Injury Clinical Trial

Official title:

Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664646
• Other study ID #: B4373-P
• Secondary ID: 1I21RX004373-01A
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: Jill Wecht, EdD
• Phone: (718) 584-9000
• Email: jm.wecht[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• DS8R
transcutaneous stimulation of the spinal cord.

Other:
• Arm Ergometry
Study 1 will use the arm ergometry as a form of exercise.
• Cool Environment
Study 2 will be completed in a cool environment setting.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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