NCT02660073

Brief Summary

Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian and military personnel in the United States. Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes and coronary artery disease. These are devastating problems that occur frequently because of changes in body composition and reduced level of physical activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI. Functional electrical stimulation (FES) is an effective rehabilitation tool that has been used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However, its ability to reverse skeletal muscle wasting is modest; most studies report limited gains in muscle mass and workload with highly variables outcomes from one study to another. This proposal was stimulated by the findings that a program of neuromuscular electrical stimulation resistance exercise prior to initiating functional electrical stimulation lower extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES. The specific objectives for the current proposal are to compare the impact of FES following evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could potentially have significant effects on thousands of people that will experience an SCI in the future as well as those living with SCI where prolonged paralysis is a major quality of life issue. There is a major need to investigate the mechanisms lead to maximize the benefits of FES applications and to understand cellular or molecular events that are associated with muscle hypertrophy and lead to promoting metabolic health after SCI. The designed study will provide a greater understanding regarding utilization of energy sources (like fats and sugars) in muscle

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

4.9 years

First QC Date

December 11, 2015

Last Update Submit

February 26, 2021

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

  • Glucose uptake

    by measuring glucose effectiveness

    24 weeks

  • Insulin Sensitivity

    By performing frequent blood drawing of 32 samples over 3 hour period while the patient is fasting.

    24 weeks

  • Oxygen Uptake

    24 weeks

Secondary Outcomes (2)

  • Skeletal Muscle Size

    24 weeks

  • Visceral Fat

    24 weeks

Other Outcomes (2)

  • Skeletal Muscle protein expressions

    24 weeks

  • Mitochondrial Enzyme Activities

    24 weeks

Study Arms (2)

NMES+FES group

EXPERIMENTAL

NMES+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of surface NMES and ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks +3 weeks for measurements.

Device: NMES+FES

Control+FES group

EXPERIMENTAL

Control+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of passive leg extension/flexion with no ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks+3 weeks for measurements.

Device: Control+FES

Interventions

NMES+FESDEVICE

12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling.

Also known as: (NMES; Theratouch)+(FES; RTI300 Bike)
NMES+FES group
Control+FESDEVICE

12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling.

Also known as: Control+(FES; RTI300 Bike)
Control+FES group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be between 18-65 years old,
  • men/women,
  • Greater than one year post SCI,
  • with body mass index (BMI) \< 30 Kg/m2. .
  • Participants must have traumatic motor complete or incomplete SCI C5-L2 level of injury, American Spinal Injury Impairment Scale Classification (AIS A, B or C).

You may not qualify if:

  • Participants with any of the following pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater), hematocrit above 50% or urinary tract infection or symptoms.
  • Participants with osteoporosis (T-score equal or worse than -2.5 according to the World Health recommendation) will be excluded.
  • Pregnant women and women who will be involved and become pregnant during the course of the study will be excluded as well.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

James J. Peters VA Medical Center

The Bronx, New York, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth Unviersity

Richmond, Virginia, United States

Location

Related Publications (5)

  • Gorgey AS, Venigalla S, Deitrich JN, Ballance WB, Carter W, Lavis T, Adler RA. Electrical stimulation paradigms on muscle quality and bone mineral density after spinal cord injury. Osteoporos Int. 2025 Jun;36(6):1039-1051. doi: 10.1007/s00198-025-07482-5. Epub 2025 Apr 22.

    PMID: 40261334DERIVED

  • Gorgey AS, Khalil RE, Carter W, Rivers J, Chen Q, Lesnefsky EJ. Skeletal muscle hypertrophy and enhanced mitochondrial bioenergetics following electrical stimulation exercises in spinal cord injury: a randomized clinical trial. Eur J Appl Physiol. 2025 Apr;125(4):1075-1089. doi: 10.1007/s00421-024-05661-6. Epub 2024 Nov 22.

    PMID: 39578309DERIVED

  • Gorgey AS, Khalil RE, Carter W, Ballance B, Gill R, Khan R, Goetz L, Lavis T, Sima AP, Adler RA. Effects of two different paradigms of electrical stimulation exercise on cardio-metabolic risk factors after spinal cord injury. A randomized clinical trial. Front Neurol. 2023 Sep 22;14:1254760. doi: 10.3389/fneur.2023.1254760. eCollection 2023.

    PMID: 37808500DERIVED

  • Goldsmith JA, Lai RE, Garten RS, Chen Q, Lesnefsky EJ, Perera RA, Gorgey AS. Visceral Adiposity, Inflammation, and Testosterone Predict Skeletal Muscle Mitochondrial Mass and Activity in Chronic Spinal Cord Injury. Front Physiol. 2022 Feb 10;13:809845. doi: 10.3389/fphys.2022.809845. eCollection 2022.

    PMID: 35222077DERIVED

  • Gorgey AS, Khalil RE, Davis JC, Carter W, Gill R, Rivers J, Khan R, Goetz LL, Castillo T, Lavis T, Sima AP, Lesnefsky EJ, Cardozo CC, Adler RA. Skeletal muscle hypertrophy and attenuation of cardio-metabolic risk factors (SHARC) using functional electrical stimulation-lower extremity cycling in persons with spinal cord injury: study protocol for a randomized clinical trial. Trials. 2019 Aug 23;20(1):526. doi: 10.1186/s13063-019-3560-8.

    PMID: 31443727DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of SCI Research

Study Record Dates

First Submitted

December 11, 2015

First Posted

January 21, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

US(3)