Spinal Cord InjuriesNCT04858178
Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes
A study testing Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia in people with Spinal Cord Injuries and Autonomic Imbalance, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia
- What is being tested?
- Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Official title: Transcutaneous Spinal 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.
- Conditions
- Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic; Hypotension, Neurogenic
- Being tested
- Tests of sympathetic inhibition, Tests of sympathetic activation, Testing of autonomic dysreflexia, Transcutaneous spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests of sympathetic inhibitionDiagnostic 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 activationDiagnostic 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 dysreflexiaDiagnostic test
Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
Transcutaneous spinal cord stimulationDevice
Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with spinal cord injury | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Diagnostic Test: Testing of autonomic dysreflexia; Device: Transcutaneous spinal cord stimulation |
| Individuals without spinal cord injury | Experimental | Not described Receives: Diagnostic Test: Tests of sympathetic inhibition; Diagnostic Test: Tests of sympathetic activation; Device: Transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, average 3 months
Secondary outcomes (6)
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.
Measured: Through study completion, average 3 months
Beat-to-beat heart rate
Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Measured: Through study completion, average 3 months
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.
Measured: Through study completion, average 3 months
Continuous galvanic skin response
Changes from resting state conductance with be quantified with a smartwatch.
Measured: Through study completion, average 3 months
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).
Measured: Baseline, prior to initial laboratory diagnostic testing session
Quantify secondary autonomic complications
Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).
Measured: Baseline, prior to initial laboratory diagnostic testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start17 Feb 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Principal investigator, Ryan Solinsky, Spaulding Rehabilitation Hospital
- Investigators
- Ryan Solinsky, MD, Principal investigator, Spaulding Rehabilitation Hospital / Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858178
- Sponsor's protocol ID
- 2021P001100
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes
- ClinicalTrials.gov ID
- NCT04858178
- Acronym / sponsor ID
- 2021P001100
- Conditions
- Spinal Cord Injuries, Autonomic Imbalance, Autonomic Dysreflexia, Orthostatic; Hypotension, Neurogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with spinal cord injury | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of sympathetic activation, Diagnostic Test: Testing of autonomic dysreflexia, Device: Transcutaneous spinal cord stimulation |
| Individuals without spinal cord injury | Experimental | Diagnostic Test: Tests of sympathetic inhibition, Diagnostic Test: Tests of sympathetic activation, Device: Transcutaneous spinal cord stimulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tests of sympathetic inhibitionBolus 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. | Diagnostic test | Individuals with spinal cord injury, Individuals without spinal cord injury |
| Tests of sympathetic activationCold 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). | Diagnostic test | Individuals with spinal cord injury, Individuals without spinal cord injury |
| Testing of autonomic dysreflexiaCold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested. | Diagnostic test | Individuals with spinal cord injury |
| Transcutaneous spinal cord stimulationTranscutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation. | Device | Individuals with spinal cord injury, Individuals without spinal cord injury |
Primary outcome
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.
6 secondary outcomes
Muscle sympathetic nerve activity
Time frame: Through study completion, average 3 months
Beat-to-beat heart rate
Time frame: Through study completion, average 3 months
Beat-to-beat blood pressure
Time frame: Through study completion, average 3 months
Continuous galvanic skin response
Time frame: Through study completion, average 3 months
Quantify autonomic dysreflexia and orthostatic hypotension
Time frame: Baseline, prior to initial laboratory diagnostic testing session
Quantify secondary autonomic complications
Time frame: Baseline, prior to initial laboratory diagnostic testing session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Solinsky, MD principal investigator
Spaulding Rehabilitation Hospital / Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tests of sympathetic inhibition, Tests of sympathetic activation and Testing of autonomic dysreflexia in people with Spinal Cord Injuries and Autonomic Imbalance, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valsalva Maneuver Phase II (time frame: Through study completion, average 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.