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High Frequency SARS for Spinal Cord Injury (SARS600 Trial)

Q: Are there any vacancies in this research project yet?

<p>This medical trial's listing on clinicaltrials.gov shows it is currently not recruiting participants. It was initially posted July 1st, 2022 and last modified July 15th, 2022; however, 352 other trials are presently accepting patients.</p>

Phase < 1

Waitlist Available

Led By Dennis Bourbeau, PhD

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

Suprasacral SCI

Neurologically stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

SARS600 Trial Summary

This trial is testing a new way to stimulate the nerves that control the bladder, to see if it can be emptied without also cutting the nerves that cause reflex contractions.

Who is the study for?

This trial is for adults with spinal cord injury who already use a SARS System to manage bladder function. They should be neurologically stable and not have any major urethral damage, active infections, open sores near the pelvis, or bleeding disorders.Check my eligibility

What is being tested?

The study tests if stimulating sacral roots at certain frequencies can help empty the bladder without cutting nerves. Participants with an implanted device will try new stimulation patterns aimed at relaxing the sphincter to improve bladder emptying.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation and possible irritation at the site of implantation. There might also be risks related to changes in bladder or bowel function due to altered nerve stimulation.

SARS600 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is above my lower back.

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My neurological condition is stable.

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My bones have stopped growing.

SARS600 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

urethral sphincter pressure

SARS600 Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,595 Total Patients Enrolled

Dennis Bourbeau, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

3 Previous Clinical Trials

26 Total Patients Enrolled

Media Library

Finetech-Brindley Sacral Anterior Roots Stimulation System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05214378 — Phase < 1

Spinal Cord Injury Research Study Groups: Treatment Arm

Spinal Cord Injury Clinical Trial 2023: Finetech-Brindley Sacral Anterior Roots Stimulation System Highlights & Side Effects. Trial Name: NCT05214378 — Phase < 1

Finetech-Brindley Sacral Anterior Roots Stimulation System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05214378 — Phase < 1

Frequently Asked Questions

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

Are there any vacancies in this research project yet?

"This medical trial's listing on clinicaltrials.gov shows it is currently not recruiting participants. It was initially posted July 1st, 2022 and last modified July 15th, 2022; however, 352 other trials are presently accepting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Frequency SARS for Neurogenic Bladder and Bowel Emptying

2022. "High Frequency SARS for Neurogenic Bladder and Bowel Emptying". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05214378.