Impact of transcutaneous spinal cord stimulation on autonomic cardiovascular control and upper-body exercise performance in individuals with a spinal cord injury (STIMEX-SCI): An exploratory study

niversity of Birmingham0 sites28 target enrollmentFebruary 8, 2024

Overview

Phase: 未知
Intervention: Not specified
Conditions: Chronic (>1 year) motor-complete (AIS A-B) spinal cord injury between C5-T6
Sponsor: niversity of Birmingham
Enrollment: 28
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 8, 2024

End Date

February 28, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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 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.