NCT04858178

Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Completed NA Last updated 14 April 2023

What this trial tests

NA trial testing Tests of sympathetic inhibition in Spinal Cord Injuries in 4 participants. Completed in 14 November 2022.

Timeline

17 February 2022

Primary endpoint
14 November 2022

14 November 2022

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	4
Start date	17 February 2022
Primary completion	14 November 2022
Estimated completion	14 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Tests of sympathetic inhibition
• Tests of sympathetic activation
• Testing of autonomic dysreflexia
• Transcutaneous spinal cord stimulation

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Autonomic Imbalance — all drugs for Autonomic Imbalance →
• Autonomic Dysreflexia — all drugs for Autonomic Dysreflexia →
• Orthostatic; Hypotension, Neurogenic — all drugs for Orthostatic; Hypotension, Neurogenic →

Sponsor

Spaulding Rehabilitation Hospital

Who can join

Adults 18 to 30, any sex, with Spinal Cord Injuries or Autonomic Imbalance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spinal electrical stimulation to improve sympathetic autonomic functions needed for movement and exercise after spinal cord injury: a scoping clinical review.
   Flett S, Garcia J, Cowley KC. · · 2022 · cited 20× · PMID 35894427 · DOI 10.1152/jn.00205.2022
2. Transcutaneous spinal cord stimulation and its impact on cardiovascular autonomic regulation after spinal cord injury.
   Solinsky R, Burns K, Tuthill C, Hamner JW, et al · · 2024 · cited 16× · PMID 37947438 · DOI 10.1152/ajpheart.00588.2023
3. Valsalva maneuver pressure recovery time is prolonged following spinal cord injury with correlations to autonomically-influenced secondary complications.
   Solinsky R, Burns K, Taylor JA, Singer W. · · 2024 · cited 3× · PMID 38916658 · DOI 10.1007/s10286-024-01040-5
4. The Impact of Transcutaneous Spinal Cord Stimulation on Autonomic Regulation after Spinal Cord Injury: A randomized crossover trial
   Solinsky R, Burns K, Tuthill C, Hamner JW, et al · · 2023 · DOI 10.1101/2023.07.18.23292676