Clinical trial NCT05664646: Autonomic Effects of Stimulation in SCI
Official title: Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Orthostatic Hypotension
Exercise
Hypotension
Body Core Temperature
Blood Pressure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete an orthostatic tilt without stimulation, then go through transcutaneous stimulation mapping sessions to determine the optimal parameters. During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electrode placement
timeFrame: through study completion, up to 2 years
measure: Amplitude of TSCS
timeFrame: through study completion, up to 2 years
Secondary outcomes:
measure: Exercise Endurance Time
timeFrame: through study completion, up to 2 years
measure: Heart Rate Recovery Time
timeFrame: through study completion, up to 2 years
measure: Body Core Temperature
timeFrame: through study completion, up to 2 years
measure: Subjective Reporting on Thermal Comfort and Thermal Sensation
timeFrame: through study completion, up to 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Jill Wecht, EdD
role: PRINCIPAL_INVESTIGATOR
References: