Spinal Cord InjuryNMES-SCINCT07099911
Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury
A study testing NMES in people with Spinal Cord Injury, run by University of Bath at 1 site in United Kingdom.
Trial summary
Overall aim: To identify the impact and acceptability of a novel method of neuromuscular electrical stimulation (NMES) for improving glucose control using a dual stable isotope tracer OGTT in individuals with spinal cord injury (SCI). Objective 1: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- NMES
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- We are asking all individuals who meet our study criteria if they would like to take part. We are looking for both males and females who meet all the criteria on this list for either SCI or non-injured individuals:
- Individuals with SCI:
- >1-year postinjury.
- 18 years of age or above
- American Spinal Cord Injury Impairment Scale A-C.
- Level of Injury, Cervical 5-Lumbar 2.
Show all 9Show fewer
- Have capacity to provide informed consent.
- Non-injured individuals:
- 18 years of age or above
Who cannot join
- Has been diagnosed with type 2 diabetes, or actively taking a pharmaceutical to address elevated blood glucose.
- Unable to understand explanations and/or provide informed consent.
- If you cannot tolerate the NMES intervention
- Is pregnant or planning to become pregnant during the study duration
- SCI only:
- Recently trained with electrical stimulation (< 6 months)
Show all 13Show fewer
- Recent history of lower limb fractures
- Peripheral nerve injury to lower extremities
- Unresolved pressure ulcers
- Known lower motor neuron injury.
- If the research team cannot induce visible or palpable contractions of the quadricep muscle with NMES
- If they cannot tolerate the NMES intervention
- Has previously experienced uncontrolled autonomic dysreflexia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Department for Health, University of Bath
Bath, United Kingdom, BA2 7AY
Rebecca R A YOUNG, +44 (0) 1225 388388, ray27@bath.ac.uk
About this study
Official title: Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury
Overall aim: To identify the impact and acceptability of a novel method of neuromuscular electrical stimulation (NMES) for improving glucose control using a dual stable isotope tracer OGTT in individuals with spinal cord injury (SCI).
Objective 1:
Read more
- To establish the extent to which an acute bout of NMES improves health-related measures of glucose control, compared to a SHAM control trial.
- To identify the relative magnitude of effect, compared to non-injured control participants (CON).
Hypotheses:
- NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition.
- The effect will be greater in individuals with SCI compared to non-injured control participants.
Objective 2:
To investigate the real-world feasibility of NMES as a therapeutic intervention, participants with SCI will be given instructions for 2-weeks of at-home use. In-depth interviews will be conducted to evaluate acceptability and identify areas that could be adapted to effectively implement NMES in a future trial.
Participants will complete two experimental trials in a randomised crossover fashion separated by 7 days which will consist of either a sham control (SHAM) or an acute bout of NMES during a 3-h oral glucose tolerance test (OGTT). Following the experimental trial days, participants with SCI will take home a NMES device and will be given instructions for 2-weeks of at-home NMES use (Figure 1) to assess acceptability and feasibility.
- Conditions
- Spinal Cord Injury
- Being tested
- NMES, Sham (No Treatment)
- Keywords
- Neuromuscular electrical stimulation, Spinal cord injury, Glucose control, Metabolism
- 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.
NMESBehavioural
Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
Sham (No Treatment)Behavioural
Sham stimulation during a 3-h OGTT.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Experimental | Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of neuromuscular electrical stimulation (NMES), and the other with a sham condition (SHAM). After the OGTT sessions, participants will complete a 2-week period of at-home NMES use to assess real-world feasibility and acceptability through interviews. Receives: Behavioral: NMES; Behavioral: Sham (No Treatment) |
| Non-injured Control (CON) | Active comparator | Age- and sex-matched individuals without SCI. Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of NMES, and the other with a sham condition (SHAM). CON will not participate in the at-home NMES phase. Receives: Behavioral: NMES; Behavioral: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose incremental area under the curve (iAUC).
Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)
Measured: 180 minutes
Glucose Kinetics
Glucose kinetics calculated from plasma deuterated glucose enrichment, including rate of appearance of endogenous glucose, rate of disappearance of glucose, and rate of appearance of exogenous glucose.
Measured: 0, 180 minutes post ingestion
Secondary outcomes (15)
Whole-body carbohydrate oxidation
Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Measured: 0,60,120,180 minutes post-ingestion
Whole body fat oxidation
Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Measured: 0, 60, 120, 180 minutes post-ingestion
Non-oxidative glucose disposal
Non-oxidative glucose disposal
Measured: 180 minutes
Fasting plasma glucose concentration
Fasting plasma glucose concentration (mmol/L)
Measured: Baseline
Fasting plasma non-esterified fatty acid concentrations
Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Measured: Baseline
Fasting plasma lactate concentrations
Fasting plasma lactate concentrations (mmol/L)
Measured: Baseline
Postprandial non-esterified fatty acid concentrations
Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test
Measured: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion
Postprandial lactate concentrations
Postprandial lactate concentrations (mmol/L) in response to OGTT
Measured: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion
Total daily energy expenditure
Derived from indirect calorimetry and acccelerometry/heart rate monitoring.
Measured: 5 days
Acceptability of at-home NMES
Acceptability of at-home NMES obtained via a survey and semi-structured interview.
Measured: 2-weeks
Circulating endothelial cells
Circulating endothelial cells count/ml blood
Measured: 0, 60, 120, 180 minutes post-ingestion of OGTT
Circulating endothelial progenitor cells
Circulating endothelial progenitor cell count/100 leukocytes
Measured: 0, 60, 120, 180 minutes post-ingestion of OGTT
Tumor Necrosis Factor alpha (TNF-α)
Tumor Necrosis Factor alpha (TNF-α) (pg/mL)
Measured: 0, 60, 120, 180 minutes post-ingestion of OGTT
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) (pg/mL)
Measured: 0, 60, 120, 180 minutes post-ingestion of OGTT
Interferon gamma (IFN-γ)
Interferon gamma (IFN-γ) (pg/mL)
Measured: 0,60,120,180 minutes post-ingestion of OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start8 Aug 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Jennifer Maher, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099911
- Sponsor's protocol ID
- 346844
- Other IDs
- SBF009\1017
- Acronym
- NMES-SCI
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07099911
- Acronym / sponsor ID
- NMES-SCI / 346844
- Conditions
- Spinal Cord Injury
- Keywords
- Neuromuscular electrical stimulation, Spinal cord injury, Glucose control, Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 8 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- 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.
Overall aim: To identify the impact and acceptability of a novel method of neuromuscular electrical stimulation (NMES) for improving glucose control using a dual stable isotope tracer OGTT in individuals with spinal cord injury (SCI).
Objective 1:
- To establish the extent to which an acute bout of NMES improves health-related measures of glucose control, compared to a SHAM control trial.
- To identify the relative magnitude of effect, compared to non-injured control participants (CON).
Hypotheses:
- NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition.
- The effect will be greater in individuals with SCI compared to non-injured control participants.
Objective 2:
To investigate the real-world feasibility of NMES as a therapeutic intervention, participants with SCI will be given instructions for 2-weeks of at-home use. In-depth interviews will be conducted to evaluate acceptability and identify areas that could be adapted to effectively implement NMES in a future trial.
Participants will complete two experimental trials in a randomised crossover fashion separated by 7 days which will consist of either a sham control (SHAM) or an acute bout of NMES during a 3-h oral glucose tolerance test (OGTT). Following the experimental trial days, participants with SCI will take home a NMES device and will be given instructions for 2-weeks of at-home NMES use (Figure 1) to assess acceptability and feasibility.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | Experimental | Behavioral: NMES, Behavioral: Sham (No Treatment)Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of neuromuscular electrical stimulation (NMES), and the other with a sham condition (SHAM). After the OGTT sessions, participants will complete a 2-week period of at-home NMES use to assess real-world feasibility and acceptability through interviews. |
| Non-injured Control (CON) | Active comparator | Behavioral: NMES, Behavioral: Sham (No Treatment)Age- and sex-matched individuals without SCI. Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of NMES, and the other with a sham condition (SHAM). CON will not participate in the at-home NMES phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- We are asking all individuals who meet our study criteria if they would like to take part. We are looking for both males and females who meet all the criteria on this list for either SCI or non-injured individuals:
- >1-year postinjury.
- 18 years of age or above
- American Spinal Cord Injury Impairment Scale A-C.
- Level of Injury, Cervical 5-Lumbar 2.
Key exclusion criteria (13 listed)
- Has been diagnosed with type 2 diabetes, or actively taking a pharmaceutical to address elevated blood glucose.
- Unable to understand explanations and/or provide informed consent.
- If you cannot tolerate the NMES intervention
- Is pregnant or planning to become pregnant during the study duration
- Recently trained with electrical stimulation (< 6 months)
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 |
|---|---|---|
| NMESAcute bout of neuromuscular electrical stimulation during a 3-h OGTT. | Behavioural | Non-injured Control (CON), Spinal Cord Injury |
| Sham (No Treatment)Sham stimulation during a 3-h OGTT. | Behavioural | Non-injured Control (CON), Spinal Cord Injury |
Primary outcome
Glucose incremental area under the curve (iAUC).
Time frame: 180 minutes
Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)
Glucose Kinetics
Time frame: 0, 180 minutes post ingestion
Glucose kinetics calculated from plasma deuterated glucose enrichment, including rate of appearance of endogenous glucose, rate of disappearance of glucose, and rate of appearance of exogenous glucose.
15 secondary outcomes
Whole-body carbohydrate oxidation
Time frame: 0,60,120,180 minutes post-ingestion
Whole body fat oxidation
Time frame: 0, 60, 120, 180 minutes post-ingestion
Non-oxidative glucose disposal
Time frame: 180 minutes
Fasting plasma glucose concentration
Time frame: Baseline
Fasting plasma non-esterified fatty acid concentrations
Time frame: Baseline
Fasting plasma lactate concentrations
Time frame: Baseline
Postprandial non-esterified fatty acid concentrations
Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion
Postprandial lactate concentrations
Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion
Total daily energy expenditure
Time frame: 5 days
Acceptability of at-home NMES
Time frame: 2-weeks
Circulating endothelial cells
Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT
Circulating endothelial progenitor cells
Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT
Tumor Necrosis Factor alpha (TNF-α)
Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT
Interleukin-6 (IL-6)
Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT
Interferon gamma (IFN-γ)
Time frame: 0,60,120,180 minutes post-ingestion of OGTT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Spinal Cord Injury, run by University of Bath at 1 site in United Kingdom.
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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca A Young (+44 (0)1225 388388, ray27@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose incremental area under the curve (iAUC). (time frame: 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.