Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Mass General Brigham

Status: Completed

Conditions: Orthostatic; Hypotension, Neurogenic; Spinal Cord Injuries; Autonomic Imbalance; Autonomic Dysreflexia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04858178

2021P001100

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Individuals with spinal cord injury

Experimental group

Treatment:

Diagnostic Test: Tests of sympathetic activation

Device: Transcutaneous spinal cord stimulation

Diagnostic Test: Testing of autonomic dysreflexia

Diagnostic Test: Tests of sympathetic inhibition

Individuals without spinal cord injury

Experimental group

Treatment:

Diagnostic Test: Tests of sympathetic activation

Device: Transcutaneous spinal cord stimulation

Diagnostic Test: Tests of sympathetic inhibition