At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- NMES (behavioural), Sham (No Treatment) (behavioural)
- How long the study runs
- Study runs about 25 months (dates as stated)
- About the drug or intervention
- NMES — behavioural: Acute bout of neuromuscular electrical stimulation during a 3-h OGTT. · Sham (No Treatment) — behavioural: Sham stimulation during a 3-h OGTT.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 20
- Started
- 2025-08-08
- Last checked
- 2025-08
Plain English Summary
What is this study?
- • Testing a new treatment for spinal cord injury
- • NA - 20 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with spinal cord injury
Where?
- • Bath - Department for Health, University of Bath
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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.
Who cannot take part
- ✗Has been diagnosed with type 2 diabetes, or actively taking a pharmaceutical to address elevated blood glucose.
- ✗Unable to understand explanations and/or provide agreement to take part.
- ✗If you cannot tolerate the NMES intervention
- ✗Is pregnant or planning to become pregnant during the study duration
- ✗SCI only:
See the full criteria
Where Is This Study? (1 UK site)
Department for Health, University of Bath
Bath BA2 7AY, United Kingdom
How to Get in Touch
Rebecca A Young
Sponsor contactCONTACT