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Procedure

Stand Training for Spinal Cord Injury (TSEPI Trial)

N/A
Recruiting
Led By Susan J Harkema, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Non-progressive spinal cord injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights

TSEPI Trial Summary

This trial will study the effects of lumbosacral spinal cord epidural stimulation (scES) on individuals with severe spinal cord injury (SCI) who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand.

Who is the study for?
This trial is for adults over 18 with severe spinal cord injury, unable to stand or move legs voluntarily, and experiencing issues like low blood pressure and respiratory dysfunction. They should be at least two years post-injury with stable health but can't join if they use nicotine, have certain implants, untreated conditions, or are pregnant.Check my eligibility
What is being tested?
The study tests how epidural stimulation (scES) helps recover functions affected by spinal cord injuries. Participants will receive scES aimed at improving cardiovascular function, voluntary movement of legs/trunk, or standing ability. The impact on quality of life and healthcare costs will also be evaluated.See study design
What are the potential side effects?
While the description doesn't specify side effects directly related to the interventions being studied (epidural stimulation and stand training), such procedures may cause discomfort at the stimulation site, muscle spasms or changes in blood pressure.

TSEPI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My spinal cord injury is not getting worse.
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It has been over 2 years since my injury.
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I have trouble controlling my bladder or emptying it completely.
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My lung function is at least 15% below what is expected for someone my age and size.
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I cannot move all the joints in my legs on my own.
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I cannot stand up on my own.

TSEPI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 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
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments
Recovery of voluntary movement as assessed by functional movement assessments

TSEPI Trial Design

4Treatment groups
Experimental Treatment
Group I: Voluntary Movement Epidural StimulationExperimental Treatment1 Intervention
Participants assigned to this group will receive epidural stimulation specific for voluntary movement.
Group II: Voluntary Movement ES + Stand TrainingExperimental Treatment2 Interventions
Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.
Group III: Cardiovascular Epidural StimulationExperimental Treatment1 Intervention
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.
Group IV: Cardiovascular ES + Stand TrainingExperimental Treatment2 Interventions
Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,948 Total Patients Enrolled
Christopher Reeve Paralysis FoundationOTHER
5 Previous Clinical Trials
1,759 Total Patients Enrolled
Susan J Harkema, PhDPrincipal InvestigatorUniversity of Louisville
1 Previous Clinical Trials
5 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are currently engaged in this investigation?

"Affirmative. Clinicaltrials.gov has made it evident that the trial is currently looking for participants, with its initial posting dating back to November 8th 2017 and latest update on November 14th 2022. As of now, 36 recruits are needed from a solitary medical centre."

Answered by AI

Is there any availability for participants in this experiment?

"Affirmative. Clinicaltrials.gov documents this clinical trial as actively recruiting participants, having been posted on 8th November 2017 and amended 14th Nov 2022. Thirty-six individuals are needed from a single clinic site."

Answered by AI
~3 spots leftby Dec 2024