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Spinal Cord Stimulation

Device-Assisted Exercise for Spinal Cord Injury

N/A

Recruiting

Led By Jill Wecht, EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

Study Summary

This trial tests if a device can help people exercise longer and recover faster, and may help regulate body temperature.

Who is the study for?

This trial is for individuals with a spinal cord injury at levels C3-T1, classified as AIS A or B, who are non-ambulatory and have had their injury for over a year. Participants must be on stable medications for 30 days and commit to 7 visits in 60 days. It's not suitable for those with recent seizures, psychological disorders, substance abuse, open skin lesions on the spine, ventilator dependence, other neurological disorders or head trauma.Check my eligibility

What is being tested?

The study tests if transcutaneous spinal cord stimulation can improve blood pressure control and exercise endurance during arm cycling exercises. It also examines whether this stimulation aids body temperature regulation in cool environments.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar stimulations may cause discomfort at the site of application, muscle spasms or changes in blood pressure which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amplitude of TSCS

Electrode placement

Secondary outcome measures

Body Core Temperature

Exercise Endurance Time

Heart Rate Recovery Time

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: With stimulationActive Control3 Interventions

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.

Group II: Without stimulationPlacebo Group2 Interventions

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,264 Total Patients Enrolled

Jill Wecht, EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

5 Previous Clinical Trials

217 Total Patients Enrolled

Media Library

DS8R (Spinal Cord Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05664646 — N/A

Spinal Cord Injury Research Study Groups: Without stimulation, With stimulation

Spinal Cord Injury Clinical Trial 2023: DS8R Highlights & Side Effects. Trial Name: NCT05664646 — N/A

DS8R (Spinal Cord Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664646 — N/A

Frequently Asked Questions

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

Is this trial seeking elderly participants?

"This research project has a strict age range for recruitment; participants must be over the age of 35 and below 50."

Answered by AI

Are applicants still being accepted for participation in this research project?

"From the information available on clinicaltrials.gov, this trial is no longer actively recruiting participants; it was initially posted on July 3rd 2023 and last updated December 15th 2022. Nevertheless, 359 other trials are currently open to prospective candidates."

Answered by AI

To what purpose is this experiment intended?

"This clinical trial will monitor efficacy over a period of two years, with the principal measure being Amplitude of TSCS. Secondary objectives include assessing how quickly Heart Rate Recovery Time returns to baseline when compared against no stimulation, determining if TSCS helps maintain Body Core Temperature in cool climates versus nothing, and gauging whether there is an improvement in Subjective Reporting on Thermal Comfort and Thermal Sensation between groups that are given stimulation or not."

Answered by AI

Who is the target demographic for this medical research?

"The study is seeking 20 volunteers aged 35-50, who have sustained spinal cord injuries at least a year ago. The participants must be non-ambulatory and fall within levels C3 to T1 of the American Spinal Injury Association (AIS A or B). Additionally, they should be on a stable medication regimen for 30 days prior to enrollment and commit to seven visits across 60 days."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autonomic Effects of Stimulation in SCI

2023. "Autonomic Effects of Stimulation in SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664646.