Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT07099911
• Lead Sponsor: University of Bath

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-25
• Status Verified: 2025-08
• Study First Posted: 2025-08-01
• Last Update Submitted: 2025-08-03
• Last Update Posted: 2025-08-07
• Study Start: 2025-08-08
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glucose incremental area under the curve (iAUC).	180 minutes	Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)
Glucose Kinetics	0, 180 minutes post ingestion	Glucose kinetics calculated from plasma deuterated glucose enrichment, including rate of appearance of endogenous glucose, rate of disappearance of glucose, and rate of appearance of exogenous glucose.

Secondary Outcome Measures

Name	Time	Method
Whole-body carbohydrate oxidation	0,60,120,180 minutes post-ingestion	Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Whole body fat oxidation	0, 60, 120, 180 minutes post-ingestion	Assessed via indirect calorimetry during 180-min OGTT (60-min intervals)
Non-oxidative glucose disposal	180 minutes	Non-oxidative glucose disposal
Fasting plasma glucose concentration	Baseline	Fasting plasma glucose concentration (mmol/L)
Fasting plasma non-esterified fatty acid concentrations	Baseline	Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Fasting plasma lactate concentrations	Baseline	Fasting plasma lactate concentrations (mmol/L)
Postprandial non-esterified fatty acid concentrations	15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion	Postprandial non-esterified fatty acid concentrations (mmol/L) in response to oral glucose tolerance test
Postprandial lactate concentrations	15, 30, 45, 60, 90, 120, 150, 180 minutes post-ingestion	Postprandial lactate concentrations (mmol/L) in response to OGTT
Total daily energy expenditure	5 days	Derived from indirect calorimetry and acccelerometry/heart rate monitoring.
Acceptability of at-home NMES	2-weeks	Acceptability of at-home NMES obtained via a survey and semi-structured interview.
Circulating endothelial cells	0, 60, 120, 180 minutes post-ingestion of OGTT	Circulating endothelial cells count/ml blood
Circulating endothelial progenitor cells	0, 60, 120, 180 minutes post-ingestion of OGTT	Circulating endothelial progenitor cell count/100 leukocytes
Tumor Necrosis Factor alpha (TNF-α)	0, 60, 120, 180 minutes post-ingestion of OGTT	Tumor Necrosis Factor alpha (TNF-α) (pg/mL)
Interleukin-6 (IL-6)	0, 60, 120, 180 minutes post-ingestion of OGTT	Interleukin-6 (IL-6) (pg/mL)
Interferon gamma (IFN-γ)	0,60,120,180 minutes post-ingestion of OGTT	Interferon gamma (IFN-γ) (pg/mL)

Trial Locations

Locations (1)

Department for Health, University of Bath; 🇬🇧 Bath, United Kingdom