Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Louisville, Louisville, KYSpinal Cord InjuryStanding, Stepping and Voluntary Movement with spinal cord Epidural Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study the effects of electrical stimulation on the spinal cord in people with paralysis, in hopes of restoring some function.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Baseline, 160 sessions (1 year)

Year 1
Change from baseline in bladder capacity after 160 sessions (1 year)
Change from baseline in bladder compliance after 160 sessions (1 year)
Change from baseline in bladder voiding efficiency after 160 sessions (1 year)
Change from baseline in bowel sensation after 160 sessions (1 year)
Change from baseline in detrusor pressures during filling after 160 sessions (1 year)
Change from baseline in forced expiratory volume in one second (FEV1) after 160 sessions (1 year)
Change from baseline in forced vital capacity (FVC) after 160 sessions (1 year)
Change from baseline in maximum inspiratory pressure (MIP) after 160 sessions (1 year)
Change from baseline in mean resting anal pressure after 160 sessions (1 year)
Change from baseline in mean squeeze increase pressure after 160 sessions (1 year)
Change from baseline in mean squeeze pressure after 160 sessions (1 year)
Change from baseline in resting metabolic rate after 160 sessions (1 year)
Change from baseline in squeeze anal canal length after 160 sessions (1 year)
Change from baseline of lower extremity independence time during 10 min standing bout after 160 sessions (1 year)
Change from baseline of number of consecutive hip flexion repetitions performed within one minute after 160 sessions (1 year)
Change from baseline of stepping independence time during 6 min stepping bout after 160 sessions (1 year)
Change in baseline in maximum expiratory pressure (MEP) after 160 sessions (1 year)
Change in baseline in sexual function after 160 sessions (1 year)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Stand, Step and Voluntary Training
1 of 1

Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation · No Placebo Group · N/A

Stand, Step and Voluntary TrainingExperimental Group · 2 Interventions: Standing and Stepping, Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation · Intervention Types: Other, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 160 sessions (1 year)

Who is running the clinical trial?

Susan HarkemaLead Sponsor
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
48 Previous Clinical Trials
63,372 Total Patients Enrolled
Susan Harkema, PhDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
54 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have had your injury at least 2 years ago.
You are in good health without any major medical issues.
You cannot move all the joints in your legs on your own.
Your spinal cord injury is not getting worse.

Who else is applying?

What state do they live in?
Texas50.0%
Florida50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Louisville100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%

Frequently Asked Questions

Are there available vacancies for candidates to join this clinical trial?

"According to the latest information on clinicaltrials.gov, this specific medical trial is no longer recruiting patients. Initially posted in November 2020 and last edited a few weeks ago, 353 other studies are presently searching for participants instead." - Anonymous Online Contributor

Unverified Answer

What are the projected results of this experiment?

"This monitored clinical trial has the primary aim of observing the alteration in lower extremity autonomy during a 10 minute standing session after 160 sessions (1 year). Additionally, secondary objectives include tracking changes in maximum expiratory pressure (MEP) via Respiratory Motor Control Assessment (RMCA), bowel sensation evaluated with anorectal manometry measured in mL, and forced vital capacity (FVC) assessed by means of Respiratory Motor Control Analysis." - 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.