RecruitingNot ApplicableNCT07099911

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

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


Sponsor

University of Bath

Enrollment

20 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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.
  • 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:
  • years of age or above

Exclusion Criteria13

  • 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

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Interventions

BEHAVIORALNMES

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

BEHAVIORALSham (No Treatment)

Sham stimulation during a 3-h OGTT.


Locations(1)

Department for Health, University of Bath

Bath, United Kingdom, United Kingdom

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NCT07099911


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