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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 below

SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week1 and week 6 of ipr
This trial's timeline: 3 weeks for screening, Varies for treatment, and week1 and week 6 of ipr for reporting.

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 • NCT02945553
9%
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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025