NCT07099911 Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury
| NCT ID | NCT07099911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bath |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-08 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07099911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07099911 currently recruiting?
Yes, NCT07099911 is actively recruiting participants. Contact the research team at ray27@bath.ac.uk for enrollment information.
Where is the NCT07099911 trial being conducted?
This trial is being conducted at Bath, United Kingdom.
Who is sponsoring the NCT07099911 clinical trial?
NCT07099911 is sponsored by University of Bath. The trial plans to enroll 20 participants.