Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic; Hypotension, Neurogenic

In brief

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.

Key facts

Study ID

NCT04858178

Run by

Spaulding Rehabilitation Hospital

People needed

4

Starts

2022-02-17

Expected to finish

2022-11-14

Last updated by the study team

2023-04-14

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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