Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Spinal Cord Injuries Clinical Trial

Official title:

Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858178
• Other study ID #: 2021P001100
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: April 2023
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle sympathetic nerve activity	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.	Through study completion, average 3 months
Secondary	Beat-to-beat heart rate	Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.	Through study completion, average 3 months
Secondary	Beat-to-beat blood pressure	Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.	Through study completion, average 3 months
Secondary	Continuous galvanic skin response	Changes from resting state conductance with be quantified with a smartwatch.	Through study completion, average 3 months
Secondary	Quantify autonomic dysreflexia and orthostatic hypotension	Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).	Baseline, prior to initial laboratory diagnostic testing session
Secondary	Quantify secondary autonomic complications	Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).	Baseline, prior to initial laboratory diagnostic testing session