RecruitingNAINTERVENTIONAL

Neuromuscular Electrical Stimulation and Glucose Control in Spinal Cord Injury

This research explores if a technique called Neuromuscular Electrical Stimulation (NMES) can improve how people with spinal cord injuries manage their blood sugar. The first part of the study compares NMES with a "sham" (no treatment) condition during a glucose test to see if it helps the body use sugar better. It also compares the effects in people with spinal cord injuries to those without. The second part focuses on testing how practical and acceptable NMES is for people with spinal cord injuries to use at home for two weeks, gathering their feedback to help plan future studies. Participants will complete two experimental trials and a period of home use.

At a glance

Status

Recruiting

Phase

Sponsor

University of Bath

Enrolment target

Start

08 Aug 2025

Estimated completion

01 Sep 2027

Spinal Cord Injury

What is this study about?

This study is investigating a treatment called Neuromuscular Electrical Stimulation, or NMES, for people who have a spinal cord injury. NMES uses gentle electrical pulses to make muscles contract, similar to exercise. The main goal of this research is to see if NMES can help improve how a person's body manages blood sugar levels. This is important because managing blood sugar effectively is key for overall health.

Researchers want to understand two main things. First, they will compare how well NMES works against a 'sham' treatment, which means participants go through the motions but don't receive actual stimulation. This helps researchers know for sure if any improvements are due to NMES itself. They'll also compare the sugar-regulating effects in people with spinal cord injuries to people without, to understand the specific impact. The hope is that NMES will help muscles take up more sugar from the blood, which could lead to better blood sugar control.

The second important part of the study is about how practical and acceptable NMES is for everyday life. After some initial tests, individuals with spinal cord injuries will be asked to use an NMES device at home for two weeks. Researchers will talk to them in detail about their experiences to find out what they liked, what was challenging, and how the device or instructions could be made better. This feedback is crucial for designing future studies that are realistic and helpful for people living with spinal cord injuries.

Key takeaways

This study investigates if electrical muscle stimulation (NMES) can help manage blood sugar in people with spinal cord injury.
It compares NMES to a 'sham' treatment and looks at its effects versus people without spinal cord injury.
A key part is understanding how practical and acceptable NMES is for home use.
Participants will have two test days with glucose monitoring and some will use a device at home.
This research aims to improve future treatments for blood sugar control in spinal cord injury.

Who may be eligible?

This study is looking for both men and women aged 18 or older. We are inviting people with a spinal cord injury, as well as people without a spinal cord injury, to take part. For those with a spinal cord injury, it needs to have happened more than a year ago, and the injury level should be between C5 and L2 (inclusive) on the spinal column. We also use a scale called the American Spinal Cord Injury Impairment Scale, and you would need to be classified as A, B, or C.

There are also some important reasons why someone might not be able to join. For example, if you have already been diagnosed with type 2 diabetes or are taking medication for high blood sugar, this study might not be suitable. It's also not for you if you've recently had lower limb fractures, have certain nerve injuries in your legs, or have unresolved pressure sores. We also can't include pregnant individuals or those planning to become pregnant during the study.

Additionally, if the NMES device can't make your thigh muscles contract visibly, or if you can't comfortably tolerate the stimulation, you wouldn't be able to participate. We also need to make sure you can understand the study information and give your consent freely.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a spinal cord injury that happened over a year ago (or are you someone without a spinal cord injury)?
Are you NOT currently diagnosed with type 2 diabetes or taking medication for high blood sugar?
Are you NOT pregnant or planning to become pregnant during the study?
Can you physically tolerate gentle electrical stimulation on your muscles?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first come to the study center for two experimental visits, which will be about 7 days apart. During these visits, you’ll have a special glucose test where you drink a sugary solution. On one visit, you'll receive NMES treatment during this test, and on the other, you'll receive a 'sham' treatment, which feels similar but doesn’t actively stimulate the muscles. The order of these treatments will be chosen by chance.

After these two visits, if you have a spinal cord injury, you'll be given an NMES device to take home. You'll be asked to use this device at home for two weeks, following specific instructions. During and after this home-use period, researchers will talk with you about your experiences to understand how easy or difficult it was to use the device. The total duration of your participation, including the visits and the home-use period, will be a few weeks.

Potential risks and benefits

Taking part in a study like this helps researchers learn more, which could lead to better treatments in the future for people with spinal cord injuries. You might not directly benefit from taking NMES in this study, but your body’s blood sugar levels will be closely monitored, and you'll get detailed information about them. As with any medical procedure, there are potential risks, which will be fully explained to you before you decide to participate. These could include minor discomfort from the electrical stimulation, though most people tolerate NMES well. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Department for Health, University of Bath
Verified postcode
Bath, United Kingdom· Recruiting

Common questions

What is NMES?

NMES stands for Neuromuscular Electrical Stimulation. It's a method that uses small electrical pulses to make your muscles contract, similar to how they would during exercise.

What is a 'sham' treatment?

A 'sham' treatment looks and feels like the real treatment but doesn't actually deliver the active electrical stimulation. This helps researchers compare the true effects of NMES.

Will I know if I'm getting NMES or the sham treatment?

During the main part of the study, you won’t know which treatment you are receiving (either NMES or the sham) to ensure the results are unbiased. This is called 'blinding'.

What is an oral glucose tolerance test (OGTT)?

An OGTT is a test where you drink a sugary solution, and then your blood sugar levels are measured over a few hours to see how your body handles sugar.

How long does the study last?

Your involvement in the study will last a few weeks, including two experimental visits about a week apart, and then a two-week period of using the NMES device at home if you have a spinal cord injury.

How to find out more

Rebecca A Young

ray27@bath.ac.uk +44 (0)1225 388388 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.