Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07099911

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Led by University of Bath · Updated on 2025-08-07

20

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

Sponsors

U

University of Bath

Lead Sponsor

U

University of Birmingham

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with spinal cord injury more than 1 year post-injury
  • Adults aged 18 years or older
  • American Spinal Cord Injury Impairment Scale A-C
  • Level of injury between cervical 5 and lumbar 2
  • Ability to provide informed consent
  • Non-injured individuals aged 18 years or older
Not Eligible

You will not qualify if you...

  • Diagnosed with type 2 diabetes or taking medication for high blood sugar
  • Unable to understand explanations or provide informed consent
  • Unable to tolerate the NMES intervention
  • Pregnant or planning pregnancy during the study
  • For spinal cord injury participants: trained with electrical stimulation within the last 6 months
  • Recent lower limb fractures
  • Peripheral nerve injury to lower limbs
  • Unresolved pressure ulcers
  • Known lower motor neuron injury
  • If visible or palpable quadricep muscle contractions cannot be induced by NMES
  • Previous uncontrolled autonomic dysreflexia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department for Health, University of Bath

Bath, United Kingdom, United Kingdom, BA2 7AY

Actively Recruiting

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Research Team

R

Rebecca A Young

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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