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Behavioural Intervention
Neuromuscular electrical stimulation for Metabolic Diseases (SCI Trial)
N/A
Waitlist Available
Led By Ceren Yarar-Fisher, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
between the ages of 18 and 60 years;
diagnosis of traumatic SCI at the cervical or thoracic level (C5-T12) classified as AIS A (motor and sensory complete);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week1 and week 6 of ipr
Awards & highlights
SCI Trial Summary
This trial looks at whether a novel electrical stimulation program can help improve metabolism and overall health in people with spinal cord injuries.
Eligible Conditions
- Metabolic Diseases
- Spinal Cord Injury
- Muscle Atrophy
SCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week1 and week 6 of ipr
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week1 and week 6 of ipr
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in beta cell function
Change in glucose tolerance
Change in insulin sensitivity
Secondary outcome measures
Change in metabolic signaling in skeletal muscle
Change in muscle fatigue
Change in muscle strength
Side effects data
From 2019 Phase 1 & 2 trial • 25 Patients • NCT029455539%
Re-injury of ACL (graft failure)
9%
Re-injury of meniscus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Microstimulation
Neuromuscular Electrical Stimlulation
SCI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This group will receive electrical stimulation induced exercises in addition to their standard care during in-patient rehabilitation (IPR). Standard care will include respiration therapy, bed mobility, transfers, wheelchair mobility skills, bowel and bladder management, tone and spasticity management, and skills for performing other activities of daily living. Exercises will include neuromuscular electrical stimulation (NMES) induced-resistance exercise (RE) (1x/day) and NMES-aerobic exercise (1x/day) for 3 days/week.
Group II: ControlActive Control1 Intervention
This group will receive standard care plus passive dynamic exercise of the lower legs (sham treatment for NMES-RE, 1x/day) and transcutaneous electrical nerve stimulation (TENS, sham treatment for NMES-aerobic exercise, 1x/day) during IPR.
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
501,083 Total Patients Enrolled
2 Trials studying Metabolic Diseases
862 Patients Enrolled for Metabolic Diseases
University of Alabama at BirminghamLead Sponsor
1,567 Previous Clinical Trials
2,268,807 Total Patients Enrolled
5 Trials studying Metabolic Diseases
8,177 Patients Enrolled for Metabolic Diseases
Ceren Yarar-Fisher, PhDPrincipal Investigator - OSU
University of Alabama at Birmingham
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
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