Transcutaneous spinal cord stimulation for Dysautonomia

Spaulding Rehabilitation Hospital, Boston, MA
Dysautonomia+3 More ConditionsTranscutaneous spinal cord stimulation - Device
Eligibility
18 - 30
All Sexes

Study Summary

This trial is looking at whether or not transcutaneous spinal cord stimulation can help improve autonomic nervous system function in people with spinal cord injury.

Eligible Conditions
  • Dysautonomia
  • Autonomic Dysreflexia
  • Spinal Cord Injury
  • Neurogenic Orthostatic Hypotension

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Mild Intermittent Hypoxia
1
Transcutaneous spinal cord stimulation
1
Spinal Cord Epidural Stimulation

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Through study completion, average 3 months

Baseline, prior to initial laboratory diagnostic testing session
Quantify autonomic dysreflexia and orthostatic hypotension
Quantify secondary autonomic complications
Month 3
Beat-to-beat blood pressure
Beat-to-beat heart rate
Continuous galvanic skin response
Muscle sympathetic nerve activity
Valsalva Maneuver Phase II

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Mild Intermittent Hypoxia
1
Transcutaneous spinal cord stimulation
1
Spinal Cord Epidural Stimulation

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Individuals without spinal cord injury
1 of 2
Individuals with spinal cord injury
1 of 2

Experimental Treatment

4 Total Participants · 2 Treatment Groups

Primary Treatment: Transcutaneous spinal cord stimulation · No Placebo Group · N/A

Individuals without spinal cord injuryExperimental Group · 3 Interventions: Tests of sympathetic inhibition, Transcutaneous spinal cord stimulation, Tests of sympathetic activation · Intervention Types: DiagnosticTest, Device, DiagnosticTest
Individuals with spinal cord injuryExperimental Group · 4 Interventions: Testing of autonomic dysreflexia, Tests of sympathetic inhibition, Transcutaneous spinal cord stimulation, Tests of sympathetic activation · Intervention Types: DiagnosticTest, DiagnosticTest, Device, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testing of autonomic dysreflexia
2022
N/A
~10
Tests of sympathetic inhibition
2022
N/A
~10
Transcutaneous spinal cord stimulation
2022
N/A
~60
Tests of sympathetic activation
2022
N/A
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, average 3 months

Who is running the clinical trial?

Medical University of South CarolinaOTHER
871 Previous Clinical Trials
5,368,876 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
128 Previous Clinical Trials
10,681 Total Patients Enrolled
Ryan Solinsky, MDPrincipal InvestigatorSpaulding Rehabilitation Hospital / Harvard Medical School
1 Previous Clinical Trials
69 Total Patients Enrolled

Eligibility Criteria

Age 18 - 30 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This applies to everyone who wants to participate in the study.
You have a spinal cord injury.
You are an adult who has experienced a spinal cord injury due to trauma.
You have had your injury for less than one year, to make sure your body's natural response to changes in blood pressure is not affected.
You have a spinal cord injury between the first and sixth vertebrae that affects your neurological function.
References

Frequently Asked Questions

What is the present enrollment number for this trial?

"Affirmative. Clinicaltrials.gov data confirms that this trial is actively enrolling 10 patients from a single site; the project was initially posted on February 17th 2022, with its most recent update occurring on September 29th 2022." - Anonymous Online Contributor

Unverified Answer

What type of individuals is this investigation particularly targeting?

"This clinical study is seeking 10 patients aged 18-30 with a spinal cord injury which occurred within the last year. In addition, participants should have an American Spinal Injury Association Impairment Scale score of A and a neurological level of injury between T1-T6 as defined by International Standards for Neurological Classification of Spinal Cord Injury criteria." - Anonymous Online Contributor

Unverified Answer

Is there room for new participants in this clinical experiment?

"This research is recruiting participants, as per information provided on clinicaltrials.gov. The project was inaugurated on February 17th 2022 and the last update occurred September 29th 2022." - Anonymous Online Contributor

Unverified Answer

Are elderly individuals being offered enrollment in this trial?

"Enrolment in this experiment is restricted to those between 18 and 30 years old. There are 46 trials recruiting minors and 395 for seniors." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top