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Trials / Recruiting

RecruitingNCT07099911

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Novel Use of Neuromuscular Electrical Stimulation to Improve Glucose Control in Individuals With Spinal Cord Injury

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University of Bath · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALNMESAcute bout of neuromuscular electrical stimulation during a 3-h OGTT.
BEHAVIORALSham (No Treatment)Sham stimulation during a 3-h OGTT.

Timeline

Start date
2025-08-08
Primary completion
2026-09-01
Completion
2027-09-01
First posted
2025-08-01
Last updated
2025-08-07

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07099911. Inclusion in this directory is not an endorsement.