Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

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

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.

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• Spaulding Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Ryan Solinsky, MD · Spaulding Rehabilitation Hospital / Harvard Medical School

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-17

Primary Completion

2022-11-14

Completion

2022-11-14

FDA Device

Yes

Countries

• United States

Study Locations