Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
The goal of this clinical trial is to learn if non-invasive spinal cord stimulation intervention improves blood pressure regulation in individuals with chronic spinal cord injury. The main questions it aims to answer are:
* Can site specific spinal cord stimulation enhance blood pressure regulation? * Does this stimulation affect enzymes responsible for blood pressure regulation? Researchers will stimulate different sites of spinal cord and compare to see if site-specific stimulation provide blood pressure stability.
Participants will have up to six pairs of self-adhesive conductive electrodes placed on the skin over the spinal cord (midline and/or just to the left and right of midline) as cathodes and up to six pairs of self-adhesive electrodes located symmetrically on the skin over the iliac crests, clavicles, shoulders, and/or abdominal muscles (left and right of the umbilicus) as anodes for stimulation of the spinal cord.
Eligibility criteria
Qualifiers
At least 18 years old,
Stable medical condition,
Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological status assessed at 6-month period after injury or at least 6 months prior to the screening),
Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade "A," "B," or "C" above T1 spinal level according to the ASIA International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury (NLI),
Disqualifiers
Major pulmonary or cardiovascular disease unrelated to SCI,
Ventilator dependence,
Painful musculoskeletal dysfunction that might interfere with testing or stimulation,
Unhealed fracture that might interfere with testing or stimulation,
Trial design
Treatments tested in this trial
- Spinal Cord Transcutaneous Stimulation
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Louisville
Lead sponsor
Kentucky Spinal Cord and Head Injury Research Board
Collaborator
Source ClinicalTrials.gov