Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

NCT ID: NCT04858178

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2022-11-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Individuals with spinal cord injury

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: 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.

Tests of sympathetic activation

Intervention Type: 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).

Testing of autonomic dysreflexia

Intervention Type: DIAGNOSTIC_TEST

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

Transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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

Individuals without spinal cord injury

Group Type: EXPERIMENTAL

Tests of sympathetic inhibition

Intervention Type: 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.

Tests of sympathetic activation

Intervention Type: 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).

Transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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).

Intervention Type: DIAGNOSTIC_TEST

Testing of autonomic dysreflexia

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

Intervention Type: DIAGNOSTIC_TEST

Transcutaneous spinal cord stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ryan Solinsky

Clinician-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Solinsky, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital / Harvard Medical School

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P001100

Identifier Type: -

Identifier Source: org_study_id