NCT04858178

Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spinal Cord Injuries
• Autonomic Imbalance
• Autonomic Dysreflexia
• Orthostatic; Hypotension, Neurogenic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Tests of sympathetic inhibition	Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.
DIAGNOSTIC_TEST	Tests of sympathetic activation	Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).
DIAGNOSTIC_TEST	Testing of autonomic dysreflexia	Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
DEVICE	Transcutaneous spinal cord stimulation	Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.

Timeline

• Start date: 2022-02-17
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2021-04-26
• Last updated: 2023-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study