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Neuromodulation

Transcutaneous spinal cord stimulation for Dysautonomia

N/A
Waitlist Available
Led By Ryan Solinsky, MD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants
Participants with spinal cord injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average 3 months
Awards & highlights

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
  • Neurogenic Orthostatic Hypotension
  • Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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This applies to everyone who wants to participate in the study.
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You have a spinal cord injury.
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You are an adult who has experienced a spinal cord injury due to trauma.
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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.
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You have a spinal cord injury between the first and sixth vertebrae that affects your neurological function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Valsalva Maneuver Phase II
Secondary outcome measures
Beat-to-beat blood pressure
Beat-to-beat heart rate
Continuous galvanic skin response
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Individuals without spinal cord injuryExperimental Treatment3 Interventions
Group II: Individuals with spinal cord injuryExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tests of sympathetic activation
2022
N/A
~10
Transcutaneous spinal cord stimulation
2019
N/A
~40
Testing of autonomic dysreflexia
2022
N/A
~10
Tests of sympathetic inhibition
2022
N/A
~10

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
133 Previous Clinical Trials
11,019 Total Patients Enrolled
Medical University of South CarolinaOTHER
929 Previous Clinical Trials
7,393,813 Total Patients Enrolled
Ryan Solinsky, MDPrincipal InvestigatorSpaulding Rehabilitation Hospital / Harvard Medical School
1 Previous Clinical Trials
69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Mar 2025