Transcutaneous Stimulation in Spinal Cord Injury (SCI)

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    10
  • sponsor
    VA Office of Research and Development
Updated on 13 May 2022
systolic blood pressure
spinal cord
injuries
spinal cord disorder
spinal injury

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.

Description

Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase blood pressure and then will perform an orthostatic provocation on a tilt table during stimulation to determine differences with stim and without. The study will take approximately 7-8 study visits, of between 3-5 hours, per participant.

Details
Condition Spinal Cord Injury
Treatment DS8R, Orthostatic tilt
Clinical Study IdentifierNCT05180227
SponsorVA Office of Research and Development
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

between the ages of 21-70 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)
orthostatic hypotension (decrease in systolic blood pressure of at least 20 mmHg and/or decrease in diastolic blood pressure of at least 10 mmHg when moving from supine to upright position- will be determined in the screening process)

Exclusion Criteria

acute illness or infection
current smokers within 1 year of study
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note