Spinal Cord Stimulation for Autonomic Recovery After Acute Spinal Cord Injury
This study is testing a non-invasive treatment called transcutaneous spinal cord stimulation (tSCS) to see if it can help improve heart and blood pressure control in people who have recently had a spinal cord injury (SCI). The tSCS device, either SCONE or TESCoN, delivers mild electrical pulses to the skin over the spinal cord. Researchers want to see if this treatment can help with issues like low blood pressure when standing up (orthostatic hypotension or OH) and sudden high blood pressure (autonomic dysreflexia or AD). You may be able to join if you are 21-65 years old, have a non-progressive SCI at or above the T6 level, and are in inpatient rehabilitation or were discharged within the last 4 months. The study will enroll 26 participants and will also look at effects on bladder and bowel function.
- Study design
- This is a randomized, single-blind study with two groups, comparing tSCS to a sham (inactive) stimulation. It plans to enroll 26 participants.
- What's involved
- You will receive either active tSCS or sham stimulation during your inpatient rehabilitation and outpatient visits within three months after your injury. Your blood pressure and heart rate will be measured at the start, when you leave rehabilitation, and 6 months after your injury.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after their spinal cord injury, with measurements taken at baseline, discharge from rehabilitation, and at the 6-month mark.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Soshi Samejima, DPT, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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What this trial measures
- Change in systolic Blood Pressure (BP)Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Continuous beat-by-beat BP will be measured using a finger photoplethysmography. This will be done throughout the study, including during orthostatic challenge using sit-up test.
- Heart Rate (HR) monitoring during tSCSRepeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
Electrocardiography (ECG) at resting and during sit-up test
- frequency and severity of uncontrolled BP episodes such as OH and autonomic dysreflexia (AD) in 24 hours.Repeated measurements at baseline, post-intervention (at time of discharge from inpatient rehabilitation), and 6 months post-spinal cord injury; assessed at these 3 timepoints over 6 months.
24-hour BP monitoring obtained throughout the study using Finapres NOVA