Exercise training for Spinal Cord

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan Abilitylab, Chicago, IL
Spinal Cord+1 More
Exercise training - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Eligible Conditions

  • Spinal Cord

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 10-m walk measured at baseline and 3 weeks (10 sessions) for Dalfampridine+STDP+training and Placebo+STDP+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group.

Week 12
Change in 10-meter walk test
Week 12
Change in 6-minute walk test
Week 12
Change in MEPs
Week 12
Change in morphological characterization of corticospinal and reticulospinal pathways in MRI
Week 12
Change in MVC
Week 12
Change in surveys on ambulation, basic mobility, bowel and bladder management difficulties
Week 12
Change in International Standards for Neurological Classification of Spinal Cord Injury exam
Week 12
Change in TMEPs

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Dalfampridine (4-AP)+STDP+training
1 of 3
Dalfampridine (4-AP)+STDP+training for extended sessions
1 of 3
Placebo+STDP+training
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

44 Total Participants · 3 Treatment Groups

Primary Treatment: Exercise training · Has Placebo Group · Phase < 1

Dalfampridine (4-AP)+STDP+training for extended sessionsExperimental Group · 3 Interventions: Exercise training, STDP stimulation, Dalfampridine · Intervention Types: Behavioral, Other, Drug
Dalfampridine (4-AP)+STDP+trainingActiveComparator Group · 3 Interventions: Exercise training, STDP stimulation, Dalfampridine · Intervention Types: Behavioral, Other, Drug
Placebo+STDP+trainingPlaceboComparator Group · 3 Interventions: Exercise training, STDP stimulation, Placebo drug · Intervention Types: Behavioral, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 4
~1070
Dalfampridine
2013
Completed Phase 2
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10-m walk measured at baseline and 3 weeks (10 sessions) for dalfampridine+stdp+training and placebo+stdp+training groups. 10-m walk measured at baseline, 6 weeks (20 sessions), and 12 weeks (40 sessions) for extended sessions group.
Closest Location: Shirley Ryan Abilitylab · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2021First Recorded Clinical Trial
0 TrialsResearching Spinal Cord
3 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,239 Previous Clinical Trials
450,528 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
167 Previous Clinical Trials
13,120 Total Patients Enrolled
Monica A Perez, PT, PhDPrincipal InvestigatorShirley Ryan Ability Lab

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, aged between 18 and 85 years.
You have a spinal cord injury at least 4 weeks post injury.
You are able to perform a small contraction with dorsiflexion and hip flexor muscles.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.