Transcutaneous Stimulation for Blood Pressure in Spinal Cord Injury
This study is looking at how a device called the Biostim-5 transcutaneous spinal stimulator affects blood pressure in people with chronic spinal cord injuries (SCI) who have unstable blood pressure, especially when they stand up (orthostatic hypotension). This condition can cause dizziness and weakness. The study will try to find the best places on the spine and the best settings for the stimulator to help stabilize blood pressure. You might be able to join if you are between 18 and 75 years old, have had a spinal cord injury for at least 6 months at or above the T6 level, and experience low blood pressure (systolic blood pressure below 90mmHg) or other symptoms of low blood pressure when moving upright. The study aims to find the most effective stimulation sites and frequencies, and to see if repeated stimulation sessions improve blood pressure stability over about 6 weeks. The current status of the study is unclear.
- Study design
- This interventional study plans to enroll 5 participants. It will involve mapping to find optimal stimulation sites and frequencies.
- What's involved
- You will undergo mapping sessions to determine optimal stimulation sites and frequencies, which will take an average of 3 weeks. Throughout the experiment, lasting an average of 6 weeks, your systolic blood pressure will be measured.
- Compensation
- Not stated in the trial record.
- Follow-up
- The efficacy of stimulation on systolic blood pressure will be measured throughout the experiment, which averages 6 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Gail F Forrest, Phd · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Optimal stimulation sitesThrough Mapping and testing sessions, average of 3 weeks
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
- Optimal stimulation frequencyThrough Mapping and testing sessions, average of 3 weeks
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
- Systolic blood pressure - efficacy of stimulationThroughout the experiment, average of 6 weeks
Evaluate changes in blood pressure during an orthostatic test (comparing measurements obtained during stimulation to those obtained without). The ability of scTS to normalize SBP (to the range of 110-120) and to stabilize it over the course of a 30-min tilt test will be assessed.
- Systolic blood pressure - effect of trainingPost training, average of 2 weeks
Explore the blood pressure response to orthostatic stress with and without stimulation, following six days of repetitive 30-min customized scTS sessions
- Orthostatic symptoms questionnaireThroughout the experiment, average of 6 weeks
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), with a scale of 1-10 (10 being the most severe).