Exercise responses with transcutaneous spinal cord stimulation (using electrodes placed on the skin surface) following spinal cord injury

Not Applicable

• Conditions: Chronic (>1 year) motor-complete (AIS A-B) spinal cord injury between C5-T6; Nervous System Diseases

• Registration Number: ISRCTN17856698
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-08
• Last Update Posted: 19 February 2024
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

For individuals with spinal cord injury:
1. Male or female of at least 16 years of age.
2. Chronic SCI (non-progressive, with motor-complete paralysis) between the C5 – T6 spinal segments and =1-year post injury.
3. Documented presence of cardiovascular dysfunction including presence of persistent low resting BP and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension. This will be assessed using the The Autonomic Dysfunction Following SCI questionnaire.
4. American Spinal Injury Association Impairment Scale A or B (motor-complete SCI).
5. Willing and able to comply with all clinic visits and study-related procedures.
6. Able to understand and complete study-related questionnaires (i.e., English language speaking only).
7. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities.
8. Can move their arms/hands voluntarily to operate the arm-crank ergometer.
9. Must provide informed consent.

For non-injured individuals:
1. Male or female of at least 16 years of age.
2. Willing and able to comply with all clinic visits and study-related procedures.
3. Able to understand and complete study-related questionnaires (i.e., English language speaking only).
4. No painful musculoskeletal dysfunction, unhealed fracture, or active infection that may interfere with testing activities.
5. Must provide informed consent.

Exclusion Criteria

For individuals with a spinal cord injury:
1. Presence of severe acute medical issues that in the investigator’s judgement would adversely affect the participant’s participation in the study. Examples include, but are not limited to, acute urinary tract infections; pressure sores; active heterotopic ossification; newly changed antidepressant medications (tricyclic antidepressants); or unstable diabetes.
2. Ventilator dependent
3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
4. Cardiovascular, cerebrovascular, respiratory, metabolic, musculoskeletal, bladder, or renal disease unrelated to SCI.
5. The individual is a member of the investigational team or his/her immediate family.
6. Any implanted metal in the trunk or spinal cord (between the anode and the cathode) that would prevent the use of TSCS.
7. Have not previously suffered from brain trauma, a psychiatric disorder or epilepsy (including family history of epilepsy).
8. Are not currently taking antidepressants or neuromodulatory drugs.
9. Implanted with an epidural stimulator.
10. Females that are pregnant.
11. Does not speak English.

For non-injured individuals:
1. Individuals with any acquired SCI (i.e. traumatic, infection, cancer).
2. Any known history of cardiovascular, cerebrovascular, respiratory, metabolic, musculoskeletal, bladder, or renal disease, or individuals with diabetes mellitus. A General Health Questionnaire will be administered to screen potential participants.
3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
4. Have not previously suffered from brain trauma, a psychiatric disorder or epilepsy (including family history of epilepsy).
5. Females that are pregnant.
6. Does not speak English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1:<br>Time to fatigue assessed as the duration of exercise performed during an aerobic arm-crank exercise trial at a range of workloads corresponding to light, moderate and vigorous-intensity exercise, both with and without CV-TSCS. <br><br>Aim 2:<br>Cardiorespiratory fitness assessed as the peak oxygen uptake (V?O2peak) achieved during a graded cardiopulmonary exercise test performed on an arm-crank ergometer until volitional exhaustion. Expired gases will be collected using a calibrated, metabolic cart (Vyntus CPX, Jaeger, Germany). Cardiorespiratory fitness will be assessed pre-intervention, mid-intervention (Week 4) and post-intervention (Week 8).