Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury
NCT ID: NCT07099911
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-08-08
2027-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Spinal Cord Injury
Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of neuromuscular electrical stimulation (NMES), and the other with a sham condition (SHAM). After the OGTT sessions, participants will complete a 2-week period of at-home NMES use to assess real-world feasibility and acceptability through interviews.
NMES
Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
Sham (No Treatment)
Sham stimulation during a 3-h OGTT.
Non-injured Control (CON)
Age- and sex-matched individuals without SCI. Participants will undergo two 3-hour oral glucose tolerance tests (OGTTs) with dual stable isotope tracers in a randomized crossover design. One OGTT will be paired with an acute bout of NMES, and the other with a sham condition (SHAM). CON will not participate in the at-home NMES phase.
NMES
Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
Sham (No Treatment)
Sham stimulation during a 3-h OGTT.
Interventions
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NMES
Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.
Sham (No Treatment)
Sham stimulation during a 3-h OGTT.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
Yes
Sponsors
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University of Birmingham
OTHER
University of Bath
OTHER
Responsible Party
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Jennifer Maher
PhD Programme for Health
Locations
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Department for Health, University of Bath
Bath, United Kingdom, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBF009\1017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
346844
Identifier Type: -
Identifier Source: org_study_id
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