Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI - Trial NCT06313515

Timeline & Enrollment

Primary Outcome

Change in systolic Blood Pressure (BP) from baseline.,Change in systolic Blood Pressure during a sit-up test or head-up tilt test.,Heart rate variability recorded by electrocardiogram (ECG).

Summary

Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic
 functions like blood pressure, breathing, and heart rate. This can also make it hard for
 those living with SCI to exercise or complete their usual daily activities. The goal of this
 randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with
 non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in
 adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the
 thoracic sixth spinal segment (≥T6).
 
 The main questions the study aims to answer are:
 
 - Conduct tSCS mapping to determine the most effective location and stimulation intensity
 for BP control in individuals with motor-complete SCI ≥ T6.
 
 - Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to
 sham stimulation with exercise on improving cardiovascular function in individuals with
 motor-complete SCI ≥T6.
 
 - Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with
 arm-crank exercise on cardiovascular function in individuals with motor-complete SCI
 ≥T6.
 
 - Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired
 with arm-crank exercise.
 
 Participants will:
 
 - Receive either transcutaneous spinal cord stimulation or sham spinal cord stimulation
 while exercising on an arm-crank bicycle in the first 8 weeks.
 
 - Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week
 periods where the investigators will ask participants to come in 3x per week for spinal
 cord stimulation and exercise.
 
 - During assessment visits the researchers will perform a variety of exams including a
 neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask
 questions about quality of life and functioning.
 
 Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those
 who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective
 at improving cardiovascular and autonomic functioning in those with SCI.

ICD-10 Classifications