Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Not Applicable

Completed

• Conditions: Orthostatic; Hypotension, Neurogenic; Autonomic Imbalance; Autonomic Dysreflexia; Spinal Cord Injuries
• Interventions: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia; Device: Transcutaneous spinal cord stimulation

• Registration Number: NCT04858178
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Study Start: 2022-02-17
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individuals with spinal cord injury	Tests of sympathetic activation	-
Individuals with spinal cord injury	Tests of sympathetic inhibition	-
Individuals with spinal cord injury	Testing of autonomic dysreflexia	-
Individuals without spinal cord injury	Tests of sympathetic activation	-
Individuals without spinal cord injury	Transcutaneous spinal cord stimulation	-
Individuals with spinal cord injury	Transcutaneous spinal cord stimulation	-
Individuals without spinal cord injury	Tests of sympathetic inhibition	-

Primary Outcome Measures

Name	Time	Method
Valsalva Maneuver Phase II	Through study completion, average 3 months	Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

Secondary Outcome Measures

Name	Time	Method
Beat-to-beat blood pressure	Through study completion, average 3 months	Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.
Quantify autonomic dysreflexia and orthostatic hypotension	Baseline, prior to initial laboratory diagnostic testing session	Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).
Muscle sympathetic nerve activity	Through study completion, average 3 months	Microneurography will be performed to characterize cardiovascular autonomic phenotypes between uninjured controls and individuals with spinal cord injury. This will be quantified by spike frequency.
Continuous galvanic skin response	Through study completion, average 3 months	Changes from resting state conductance with be quantified with a smartwatch.
Beat-to-beat heart rate	Through study completion, average 3 months	Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Quantify secondary autonomic complications	Baseline, prior to initial laboratory diagnostic testing session	Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States