Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

NCT04858178 | Completed FDA Device

• 1 other identifier: 2021P001100
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Valsalva Maneuver Phase II

  Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

  Through study completion, average 3 months

Secondary Outcomes (6)

• Muscle sympathetic nerve activity

  Through study completion, average 3 months

• Beat-to-beat heart rate

  Through study completion, average 3 months

• Beat-to-beat blood pressure

  Through study completion, average 3 months

• Continuous galvanic skin response

  Through study completion, average 3 months

• Quantify autonomic dysreflexia and orthostatic hypotension

  Baseline, prior to initial laboratory diagnostic testing session

Study Arms (2)

Individuals with spinal cord injury

EXPERIMENTAL

Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia; Device: Transcutaneous spinal cord stimulation

Individuals without spinal cord injury

EXPERIMENTAL

Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Device: Transcutaneous spinal cord stimulation

Interventions

Tests of sympathetic inhibition DIAGNOSTIC_TEST

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.

Individuals with spinal cord injury; Individuals without spinal cord injury

Tests of sympathetic activation DIAGNOSTIC_TEST

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).

Individuals with spinal cord injury; Individuals without spinal cord injury

Testing of autonomic dysreflexia DIAGNOSTIC_TEST

Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.

Individuals with spinal cord injury

Transcutaneous spinal cord stimulation DEVICE

Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.

Individuals with spinal cord injury; Individuals without spinal cord injury

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia; Hypotension

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ryan Solinsky, MD

  Spaulding Rehabilitation Hospital / Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 26, 2021
• Study Start: February 17, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)