Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury (NMES-SCI)

University of Bath

Status: Enrolling

Conditions: Spinal Cord Injury

Treatments: Behavioral: NMES; Behavioral: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT07099911

SBF009\1017 (Other Grant/Funding Number)

346844

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Spinal Cord Injury

Experimental group

Description:

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.

Treatment:

Behavioral: Sham (No Treatment)

Behavioral: NMES

Non-injured Control (CON)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sham (No Treatment)

Behavioral: NMES