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
12 (estimated)
Sponsor
Kessler Foundation · Other
Who this trial is looking for
This trial is looking for individuals with a recent spinal cord injury and problems with blood pressure. Participants will receive stimulation on the spinal cord to see if it can help improve blood pressure when sitting up.
Are You a Good Fit for This Trial?
You may be able to join if
I am 7-30 days after my spinal cord injury
My injury level is at least T2
I have spinal cord injury impairment classified as A-C
I have low blood pressure symptoms
You may not be able to join if
I have a current illness or infection
I rely on a ventilator to breathe
I have had brain or spine stimulators implanted
I have a cardiac pacemaker or defibrillator
I have serious heart disease or have had a heart attack recently
I have started new heart medications in the last 5 days
I am unable to give consent
I am pregnant
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.
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly…
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.
The main questions it aims to answer are:
1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared.
2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?
Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 7-30 days after injury
* Injury level ≥T2 (thoracic level)
* American Spinal Injury Association Impairment Scale (AIS) A-C
* Exhibits at least one of the following hypotensive symptoms:
1. Baseline hypotension - resting supine or seated SBP \< 90mmHg;
2. SBP drop ≥ 20 mmH…
Inclusion Criteria:
* 7-30 days after injury
* Injury level ≥T2 (thoracic level)
* American Spinal Injury Association Impairment Scale (AIS) A-C
* Exhibits at least one of the following hypotensive symptoms:
1. Baseline hypotension - resting supine or seated 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 (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
* 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
* Initiated on new cardiac medications within the past 5 days
* Insufficient mental capacity to understand and independently provide consent
* Pregnancy
* Cancer
* Deemed unsuitable by study physician
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