Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    10
  • sponsor
    Spaulding Rehabilitation Hospital
Updated on 28 October 2022
spinal cord
nervous
spinal cord disorder
spinal cord stimulation
autonomic dysreflexia
neurologic findings
spinal injury
Accepts healthy volunteers

Summary

This study looks to characterize autonomic nervous system dysfunction after spinal cord injury and identify the potential role that transcutaneous spinal cord stimulation may play at altering neuroregulation. The autonomic nervous system plays key parts in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically encounter complications. For both individuals with spinal cord injury and uninjured controls, experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate sympathetic signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. In both study populations, transcutaneous spinal cord stimulation will be added, testing previously advocated parameters to alter autonomic neuroregulation. In accomplishing this, the investigators hope to give important insights to how the autonomic nervous system works after spinal cord injury and if it's function can be improved utilizing neuromodulation.

Details
Condition Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic; Hypotension, Neurogenic
Treatment Transcutaneous spinal cord stimulation, Tests of sympathetic inhibition, Tests of sympathetic activation, Testing of autonomic dysreflexia
Clinical Study IdentifierNCT04858178
SponsorSpaulding Rehabilitation Hospital
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All participants
age 18-30 years old
Participants with spinal cord injury
Adult onset, traumatic spinal cord injury
Time since injury 1 year, in an effort to limit baroreflex desensitization
American Spinal Injury Association Impairment Scale, A, to limit potential confounders
Neurological level of injury, T1-T6, as defined by the International Standards for Neurological Classification of Spinal Cord Injury

Exclusion Criteria

History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes
Women who are pregnant or lactating
Currently taking blood thinners
Taking anti-hypertensive or other medication that could influence any of the dependent autonomic variables
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

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