No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
5 (estimated)
Sponsor
Kessler Foundation · Other
Who this trial is looking for
This trial is looking for people with a spinal cord injury who have low blood pressure when changing positions. Participants will undergo tests with and without stimulation to see how it affects their blood pressure.
Are You a Good Fit for This Trial?
You may be able to join if
I have a spinal cord injury for at least 6 months.
My injury level is T6 or higher.
I have been classified as AIS A-D.
I have low blood pressure symptoms.
You may not be able to join if
I have a current illness that could interfere.
I depend on a ventilator.
I have had brain or spine stimulators implanted.
I have a cardiac pacemaker or defibrillator.
I have significant heart disease.
I cannot provide consent mentally.
I am currently pregnant.
I have cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).
The main questions it aims to answer are:
1. What are the various spinal si…
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).
The main questions it aims to answer are:
1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?
2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?
Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Spinal cord injury for greater than or equal to 6 months
* Injury level ≥ T6 (thoracic level)
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
* Exhibits at least one of the following hypotensive symptoms:
1. Baseline hypotension - resting supine or se…
Inclusion Criteria:
* Spinal cord injury for greater than or equal to 6 months
* Injury level ≥ T6 (thoracic level)
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
* Exhibits at least one of the following hypotensive symptoms:
1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
3. Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting
Exclusion Criteria:
* Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
* Ventilator-dependent
* History of implanted brain/spine/nerve stimulators
* Cardiac pacemaker/defibrillator or intra-cardiac lines
* Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
* Insufficient mental capacity to understand and independently provide consent
* Pregnancy
* Cancer
* Deemed unsuitable by study physician
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