Transcutaneous Spinal Cord Stimulation Combined With Arm Crank Exercise for Cardiovascular Recovery in Cervical and Upper Thoracic SCI

University of Washington1 site in 1 country16 target enrollmentApril 1, 2024

ConditionsSpinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: University of Washington
Enrollment: 16
Locations: 1
Primary Endpoint: Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 1, 2024

End Date

February 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Washington

Responsible Party

Principal Investigator

Soshi Samejima

Assistant Professor, School of Medicine

University of Washington

Eligibility Criteria

Inclusion Criteria

•Are between 21-65 years of age.
•Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
•Greater than one year post injury or diagnosis, at least 6 months from any spinal surgery.
•American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
•Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
•Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.)
•Willing and able to comply with all clinic visits and study-related procedures.
•Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
•Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
•Are with stable management of spinal cord related clinical issues (i.e., spasticity management).

Exclusion Criteria

•Have autoimmune etiology of spinal cord dysfunction/injury
•Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
•Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
•Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
•Are ventilator dependent.
•Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
•Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
•Have Intrathecal baclofen pump.
•Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
•Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.

Outcomes

Primary Outcomes

Change in systolic Blood Pressure during a sit-up test or head-up tilt test.

Time Frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months

Continuous beat-by-beat BP will be measured during a orthostatic challenge.

Change in systolic Blood Pressure (BP) from baseline.

Time Frame: Baseline

Continuous beat-by-beat BP will be measured using a finger photoplethysmography.

Heart rate variability recorded by electrocardiogram (ECG).

Time Frame: Repeated measurements before and after each 8 week-intervention block, an average of 6 months

Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.

Secondary Outcomes

Change from baseline- Capabilities of Upper Extremity Test(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
International Spinal Cord Injury Pain Basic Dataset version 2.0(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
International Spinal Cord Injury Bowel Function Dataset(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
Peak oxygen uptake (VO2peak)(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
International Standards for Neurological Classification of Spinal Cord Injury(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
Blood Pressure variability(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)
International Spinal Cord Injury Lower Urinary Tract Function Dataset(Repeated measurements before and after each 8 week-intervention block, an average of 6 months)