Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

NCT07099911 | Recruiting

• 2 other identifiers: 346844SBF009\1017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 2.To identify the relative magnitude of effect, compared to non-injured control participants (CON).
3. 3.NMES will be more effective at improving glucose control by increasing peripheral glucose uptake, relative to SHAM condition.
4. 4.The effect will be greater in individuals with SCI compared to non-injured control participants.

Conditions

Spinal Cord Injury

Keywords

Neuromuscular electrical stimulation; Spinal cord injury; Glucose control; Metabolism

Outcome Measures

Primary Outcomes (2)

• Glucose incremental area under the curve (iAUC).

  Glucose incremental area under the curve (iAUC) during oral glucose tolerance test (OGTT)

  180 minutes

• Glucose Kinetics

  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.

  0, 180 minutes post ingestion

Secondary Outcomes (15)

• Whole-body carbohydrate oxidation

  0,60,120,180 minutes post-ingestion

• Whole body fat oxidation

  0, 60, 120, 180 minutes post-ingestion

• Non-oxidative glucose disposal

  180 minutes

• Fasting plasma glucose concentration

  Baseline

• Fasting plasma non-esterified fatty acid concentrations

  Baseline

Study Arms (2)

Spinal Cord Injury

EXPERIMENTAL

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.

Behavioral: NMES; Behavioral: Sham (No Treatment)

Non-injured Control (CON)

ACTIVE COMPARATOR

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.

Behavioral: NMES; Behavioral: Sham (No Treatment)

Interventions

NMES BEHAVIORAL

Acute bout of neuromuscular electrical stimulation during a 3-h OGTT.

Non-injured Control (CON); Spinal Cord Injury

Sham (No Treatment) BEHAVIORAL

Sham stimulation during a 3-h OGTT.

Non-injured Control (CON); Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• University of Birmingham: collaborator

Study Sites (1)

Department for Health, University of Bath

Bath, United Kingdom, BA2 7AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Rebecca A Young

CONTACT

+44 (0)1225 388388; ray27@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Programme for Health

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 1, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)