Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT07099911

Run by

University of Bath

People needed

20

Starts

2025-08-08

Expected to finish

2027-09-01

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department for Health, University of Bath — Bath, United Kingdom, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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