Neuromuscular electrical stimulation to improve blood sugar control after spinal cord injury
Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury
This trial will test whether neuromuscular electrical stimulation (NMES) can improve blood sugar control in adults with spinal cord injury compared with a sham condition and with people without injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bath Academic / other |
| Locations | 1 site (Bath, United Kingdom) |
| Trial ID | NCT07099911 on ClinicalTrials.gov |
What this trial studies
Participants with spinal cord injury and non-injured controls will undergo an oral glucose tolerance test with dual stable isotope tracers to measure how an acute bout of NMES changes glucose handling compared with a sham session. The primary comparison is peripheral glucose uptake after a single NMES session versus sham, and between injured and non-injured groups. People with SCI will then be given instructions to use NMES at home for two weeks to assess real-world feasibility. In-depth interviews will be conducted to capture acceptability and identify practical barriers to home use.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who are >1 year post spinal cord injury (AIS A–C, injury level C5–L2) who can give informed consent, with non-injured adults eligible as control participants.
Not a fit: People with diagnosed type 2 diabetes or taking glucose-lowering medications, those who cannot tolerate NMES, pregnant individuals, or those with recent lower-limb fractures or peripheral nerve injury are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, NMES could offer a non-drug way to improve glucose control and reduce metabolic risk in people with spinal cord injury.
How similar studies have performed: Smaller prior studies have shown NMES can increase peripheral glucose uptake in people with SCI, but using a dual stable isotope tracer OGTT and a two-week home-feasibility component is a relatively novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bath, United Kingdom
- Department for Health, University of Bath — Bath, United Kingdom, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rebecca A Young
- Email: ray27@bath.ac.uk
- Phone: +44 (0)1225 388388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.