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NCT Number: NCT07099911

Neuromuscular Electrical Stimulation and Glucose Control in 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:

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. 2. To identify the relative magnitude of effect, compared to non-injured control participants (CON).

Hypotheses:

1. NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition. 2. 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • Have capacity to provide informed consent.

Non-injured individuals:

  • 18 years of age or above

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

NMES

Behavioral

Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.

Sham (No Treatment)

Behavioral

Sham stimulation during a 3-h OGTT.

Primary outcomes

  1. Glucose incremental area under the curve (iAUC).

    Time frame: 180 minutes

    Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)

  2. 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.

Secondary outcomes

  1. Whole-body carbohydrate oxidation

    Time frame: 0,60,120,180 minutes post-ingestion

    Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)

  2. Whole body fat oxidation

    Time frame: 0, 60, 120, 180 minutes post-ingestion

    Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)

  3. Non-oxidative glucose disposal

    Time frame: 180 minutes

    Non-oxidative glucose disposal

  4. Fasting plasma glucose concentration

    Time frame: Baseline

    Fasting plasma glucose concentration (mmol/L)

  5. Fasting plasma non-esterified fatty acid concentrations

    Time frame: Baseline

    Fasting plasma non-esterified fatty acid concentrations (mmol/L)

  6. Fasting plasma lactate concentrations

    Time frame: Baseline

    Fasting plasma lactate concentrations (mmol/L)

  7. Postprandial non-esterified fatty acid concentrations

    Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion

    Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test

  8. Postprandial lactate concentrations

    Time frame: 15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion

    Postprandial lactate concentrations (mmol/L) in response to OGTT

  9. Total daily energy expenditure

    Time frame: 5 days

    Derived from indirect calorimetry and acccelerometry/heart rate monitoring.

  10. Acceptability of at-home NMES

    Time frame: 2-weeks

    Acceptability of at-home NMES obtained via a survey and semi-structured interview.

  11. Circulating endothelial cells

    Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

    Circulating endothelial cells count/ml blood

  12. Circulating endothelial progenitor cells

    Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

    Circulating endothelial progenitor cell count/100 leukocytes

  13. Tumor Necrosis Factor alpha (TNF-α)

    Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

    Tumor Necrosis Factor alpha (TNF-α) (pg/mL)

  14. Interleukin-6 (IL-6)

    Time frame: 0, 60, 120, 180 minutes post-ingestion of OGTT

    Interleukin-6 (IL-6) (pg/mL)

  15. Interferon gamma (IFN-γ)

    Time frame: 0,60,120,180 minutes post-ingestion of OGTT

    Interferon gamma (IFN-γ) (pg/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca A Young

CONTACT

[email protected]

+44 (0)1225 388388

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury

Acronym: NMES-SCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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