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Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

Primary Purpose

Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tests of sympathetic inhibition
Tests of sympathetic activation
Testing of autonomic dysreflexia
Transcutaneous spinal cord stimulation
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Individuals with spinal cord injury

Individuals without spinal cord injury

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Beat-to-beat heart rate
Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
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.
Continuous galvanic skin response
Changes from resting state conductance with be quantified with a smartwatch.
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).
Quantify secondary autonomic complications
Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).

Full Information

First Posted
April 14, 2021
Last Updated
April 13, 2023
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04858178
Brief Title
Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes
Official Title
Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic; Hypotension, Neurogenic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individuals with spinal cord injury
Arm Type
Experimental
Arm Title
Individuals without spinal cord injury
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Tests of sympathetic inhibition
Intervention Description
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
Intervention Name(s)
Tests of sympathetic activation
Intervention Description
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
Intervention Name(s)
Testing of autonomic dysreflexia
Intervention Description
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Intervention Type
Device
Intervention Name(s)
Transcutaneous spinal cord stimulation
Intervention Description
Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.
Primary Outcome Measure Information:
Title
Valsalva Maneuver Phase II
Description
Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.
Time Frame
Through study completion, average 3 months
Secondary Outcome Measure Information:
Title
Muscle sympathetic nerve activity
Description
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.
Time Frame
Through study completion, average 3 months
Title
Beat-to-beat heart rate
Description
Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Time Frame
Through study completion, average 3 months
Title
Beat-to-beat blood pressure
Description
Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.
Time Frame
Through study completion, average 3 months
Title
Continuous galvanic skin response
Description
Changes from resting state conductance with be quantified with a smartwatch.
Time Frame
Through study completion, average 3 months
Title
Quantify autonomic dysreflexia and orthostatic hypotension
Description
Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).
Time Frame
Baseline, prior to initial laboratory diagnostic testing session
Title
Quantify secondary autonomic complications
Description
Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).
Time Frame
Baseline, prior to initial laboratory diagnostic testing session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Solinsky, MD
Organizational Affiliation
Spaulding Rehabilitation Hospital / Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

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