Spinal Cord InjuriesNCT02660073
Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury
A study testing NMES+FES in people with Spinal Cord Injuries, run by United States Department of Defense at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- NMES+FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Virginia Commonwealth Unviersity
Richmond, Virginia
James J. Peters VA Medical Center
The Bronx, New York
About this study
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
Read the detailed description
Primary Objectives Aim #1: To determine the impact of 12+12 weeks of neuromuscular electrical stimulation (NMES)+FES-LEC on oxygen uptake, insulin sensitivity and glucose uptake in adults with SCI compared to control + FES-LEC.
Aim #2: To determine the impact of 12+12 weeks of NMES+FES-LEC on skeletal muscle size, infiltration of intramuscular fat, visceral adiposity as well as fatigue resistance compared to control+ FES-LEC.
. Aim #3 : To determine the impact of 12+12 weeks of NMES+FES-LEC on determinants of energy metabolism, protein molecules involved in insulin signaling, muscle hypertrophy and oxygen uptake (IRS-1, adenosine monophosphate kinase (AMPK), glucose transporter (GLUT-4), insulin like growth factor (IGF-1), Akt, mammalian target of rapamycin (mTOR) and Peroxisome proliferator-activated receptor coactivator (PGC-1 alpha) and electron transport chain proteins compared to control + FES-LEC only.
Subjects: Forty eight chronic (1 year or more post-injury) individuals with motor complete SCI will be recruited from the Hunter Holmes McGuire VA Spinal Cord Dysfunction registry and Virginia Commonwealth University over 4 years.
Inclusion Criteria
- All participants will be between 18-65 years old, men/women,
- greater than one year post SCI,
- Body mass index (BMI) < 30 Kg/m2.
- Participants must have C5-L2 level of injury, traumatic motor complete or incomplete SCI [American Spinal Injury Impairment Scale Classification (AIS A, B or C)].
Exclusion Criteria:
- Participants with any of the following pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II diabetes mellitus, 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.
Study arms
- 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.
- 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- NMES+FES, Control+FES
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES+FESDevice
Also called (NMES; Theratouch)+(FES; RTI300 Bike)
12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling.
Control+FESDevice
Also called Control+(FES; RTI300 Bike)
12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control+FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose uptake
by measuring glucose effectiveness
Measured: 24 weeks
Insulin Sensitivity
By performing frequent blood drawing of 32 samples over 3 hour period while the patient is fasting.
Measured: 24 weeks
Oxygen Uptake
Measured: 24 weeks
Secondary outcomes (2)
Skeletal Muscle Size
Magnetic Resonance Imaging
Measured: 24 weeks
Visceral Fat
Magnetic Resonance Imaging
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Collaborators
- Hunter Holmes McGuire VA Medical Center, Virginia Commonwealth University, James J. Peters Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Ashraf S. Gorgey, Hunter Holmes McGuire VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660073
- Sponsor's protocol ID
- W81XWH-14-SCIRP-CTA
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2015
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40261334Gorgey 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.
PubMed 39578309Gorgey 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.
PubMed 37808500Goldsmith 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.
PubMed 35222077Gorgey 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.
PubMed 31443727
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02660073
- Acronym / sponsor ID
- W81XWH-14-SCIRP-CTA
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Collaborators
- Hunter Holmes McGuire VA Medical Center, Virginia Commonwealth University, James J. Peters Veterans Affairs Medical Center
- Study start
- Oct 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objectives Aim #1: To determine the impact of 12+12 weeks of neuromuscular electrical stimulation (NMES)+FES-LEC on oxygen uptake, insulin sensitivity and glucose uptake in adults with SCI compared to control + FES-LEC.
Aim #2: To determine the impact of 12+12 weeks of NMES+FES-LEC on skeletal muscle size, infiltration of intramuscular fat, visceral adiposity as well as fatigue resistance compared to control+ FES-LEC.
. Aim #3 : To determine the impact of 12+12 weeks of NMES+FES-LEC on determinants of energy metabolism, protein molecules involved in insulin signaling, muscle hypertrophy and oxygen uptake (IRS-1, adenosine monophosphate kinase (AMPK), glucose transporter (GLUT-4), insulin like growth factor (IGF-1), Akt, mammalian target of rapamycin (mTOR) and Peroxisome proliferator-activated receptor coactivator (PGC-1 alpha) and electron transport chain proteins compared to control + FES-LEC only.
Subjects: Forty eight chronic (1 year or more post-injury) individuals with motor complete SCI will be recruited from the Hunter Holmes McGuire VA Spinal Cord Dysfunction registry and Virginia Commonwealth University over 4 years.
Inclusion Criteria
- All participants will be between 18-65 years old, men/women,
- greater than one year post SCI,
- Body mass index (BMI) < 30 Kg/m2.
- Participants must have C5-L2 level of injury, traumatic motor complete or incomplete SCI [American Spinal Injury Impairment Scale Classification (AIS A, B or C)].
Exclusion Criteria:
- Participants with any of the following pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II diabetes mellitus, 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.
Study arms
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES+FES group | Experimental | Device: NMES+FESNMES+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. |
| Control+FES group | Experimental | Device: Control+FESControl+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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES+FESAlso: (NMES; Theratouch)+(FES; RTI300 Bike)12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling. | Device | NMES+FES group |
| Control+FESAlso: Control+(FES; RTI300 Bike)12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling. | Device | Control+FES group |
Primary outcome
Glucose uptake
Time frame: 24 weeks
by measuring glucose effectiveness
Insulin Sensitivity
Time frame: 24 weeks
By performing frequent blood drawing of 32 samples over 3 hour period while the patient is fasting.
Oxygen Uptake
Time frame: 24 weeks
2 secondary outcomes
Skeletal Muscle Size
Time frame: 24 weeks
Visceral Fat
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 40261334Gorgey 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.
- Derived from this study: PubMed 39578309Gorgey 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.
- Derived from this study: PubMed 37808500Gorgey 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.
- Derived from this study: PubMed 35222077Goldsmith 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.
- Derived from this study: PubMed 31443727Gorgey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES+FES in people with Spinal Cord Injuries, run by United States Department of Defense at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose uptake (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660073, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.