Clinical trial NCT04858178: Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes
Official title: Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Autonomic Imbalance
Autonomic Dysreflexia
Orthostatic; Hypotension, Neurogenic
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2021-04-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Valsalva Maneuver Phase II
timeFrame: Through study completion, average 3 months
Secondary outcomes:
measure: Muscle sympathetic nerve activity
timeFrame: Through study completion, average 3 months
measure: Beat-to-beat heart rate
timeFrame: Through study completion, average 3 months
measure: Beat-to-beat blood pressure
timeFrame: Through study completion, average 3 months
measure: Continuous galvanic skin response
timeFrame: Through study completion, average 3 months
measure: Quantify autonomic dysreflexia and orthostatic hypotension
timeFrame: Baseline, prior to initial laboratory diagnostic testing session
measure: Quantify secondary autonomic complications
timeFrame: Baseline, prior to initial laboratory diagnostic testing session
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital / Harvard Medical School
name: Ryan Solinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: