N/A
N=10
Transcutaneous Stimulation in Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT05180227 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Seated Systolic Blood Pressure — 86; 100.4; 102.7; 101.3 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DS8R (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seated Systolic Blood Pressure |
86; 100.4; 102.7; 101.3; 102.1 | — |
Summary
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Eligibility Criteria
Inclusion Criteria
- above the age of 18 years old
- individuals with traumatic spinal cord injuries at or above T6
- duration of injury if more than 1 year
- non-ambulatory
- American spinal injury association scale A, B or C
- able to provide consent
- non-ventilator
- hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
Exclusion Criteria
- acute illness or infection
- documented history of controlled or uncontrolled diabetes
- any other neurological disease other than spinal cord injury
- cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
- present of history of thrombosis in the last 12 months, severe contractures
- pregnant
Data sourced from ClinicalTrials.gov (NCT05180227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.