Skip to main content
OpenTrials
Completed

NCT Number: NCT04858178

Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Autonomic Dysreflexia Autonomic Imbalance Autonomic Nervous System Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Nervous System Diseases Orthostatic; Hypotension, Neurogenic Spinal Cord Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Testing of autonomic dysreflexia

Diagnostic Test

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

Transcutaneous Spinal Cord Stimulation

Device

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

Primary outcomes

  1. Valsalva Maneuver Phase II

    Time frame: 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 outcomes

  1. Muscle sympathetic nerve activity

    Time frame: 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.

  2. Beat-to-beat heart rate

    Time frame: Through study completion, average 3 months

    Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.

  3. Beat-to-beat blood pressure

    Time frame: 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.

  4. Continuous galvanic skin response

    Time frame: Through study completion, average 3 months

    Changes from resting state conductance with be quantified with a smartwatch.

  5. Quantify autonomic dysreflexia and orthostatic hypotension

    Time frame: 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).

  6. Quantify secondary autonomic complications

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Medical University of South Carolina

Registry information

Official study title

Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2021
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.