Novel Electrical Impedance Spectroscopy

 

The study is looking for healthy volunteers to participate.  The participant information sheet for healthy volunteers can be viewed towards the bottom of the page.  Please contact the research team if you are potentially interested and would like to discuss the study in more detail.

Study titleNovel Electrical Impedance Spectroscopy for Neurological disorders
UK Chief InvestigatorDr James Alix
Research summaryNeurological disorders often cause weakness of various muscles in body. This can be the arms or legs, or muscles around the face like the tongue. Some of these conditions are due to a main problem in the muscle structure, but many are due to problems elsewhere in the body. For example, Stroke is a disease of the brain, but it is known that there are changes to muscle after a stroke which may affect recovery.

Assessment of muscle health is therefore important in the diagnosis of neurological diseases and also in monitoring how they change over time. Despite this, the way in which muscle health is assessed is quite variable and often restricted to, for example, painful procedures, or by the clinician asking the patient to move the muscle and then judging the movement.

We have developed a quick, simple, painless way of assessing muscle health using electrical impedance spectroscopy. In this, tiny electrical pulses, that cannot be felt are used to build up an understanding of the structure of the muscle.

We have constructed a new device which we will test on patients with different conditions that affect muscle and that experts in these conditions, think would benefit from simple test to evaluate muscle. We will test our technology on healthy volunteers, patients with Motor Neurone Disease (MND), conditions that appear like MND ("mimics"), age-related muscle loss (sarcopenia) and Stroke.

We will compare the recordings from the new device against routine ways of assessing these patients. We will also undertake recordings over time to understand how our readings change. We will collect patient feedback on the device and recording procedure.

The study will enable us to understand how well the device works across conditions which could benefit from such technology. This will enable us to plan more detailed studies in the future.
Inclusion/exclusion criteriaKey Inclusion Criteria:
General inclusion criteria to be applied to all work packages:
Willing to participate in the study.
Able to read and understand English (in order to provide informed consent).
18 years or older

Work-package/disease specific:

Work-package 1 - Healthy volunteers
As per general inclusion criteria

Work-package 2 - Motor neurone disease and it mimics
In addition to the general inclusion criteria:

MND patients: under investigation for suspected ALS or fulfilling the possible, probable or definite ALS categories of the Awaji-Shima criteria.

MND mimic patients: an established electroclinical diagnosis of CIDP or MMN-CB, a genetic diagnosis of hereditary spastic paraparesis/clinical diagnosis with disease progression in keeping with the condition, muscle disease, benign fasciculations,myeloradiculopathy, myaesthenia gravis.

Work-package 3 - age-related sarcopenia
In addition to the general inclusion criteria:

Gait speed <0.8 meters per second
Reduced hand-grip strength

Work-package 4 - stroke
In addition to the general inclusion criteria:

Radiological and clinical evidence of ischaemic or haemorrhagic stroke.

Clinical evidence of upper limb or lower limb muscle spasticity (Modified Ashforth Score ≥ 2) in any of the muscle groups amenable to EIS measurement.

Key Exclusion Criteria:
Any skin condition with areas of inflammation/infection over potential recording sites.

Any co-existing neuromuscular disorder e.g. peripheral neuropathy, myopathy, myasthenia gravis.

Previous stroke.
Long term immobilisation (greater than 3 months).
Current statusActive – recruiting
LocationsRoyal Hallamshire Hospital, Sheffield
Contact detailsChief Investigator: Dr James Alix j.alix@sheffield.ac.uk
Study Coordinator: Jennie Maris jennie.maris@nhs.net
Recruitment group(s)Patients with MND
Healthy volunteers
Patients with diseases that "mimic" MND
Patients with age-related sarcopena
Stroke patients
Recruitment target(s)175 participants.
Key datesStudy start date:
Target study completion date:
Funder(s)Medical Research Council, Confidence in Concept Scheme
SponsorSheffield Teaching Hospitals NHS Foundation Trust
Study designObservational study
Intervention (if applicable)Not applicable
Phase (if applicable)Not applicable
Outcome measuresReliability of impedance measurements from muscle. Test-retest analysis will be undertaken. These will include the intra-class correlation coefficient (reliability) and Bland-Altman analysis (agreement).
Publications / Results reports
Participant Information SheetInformation Sheet for Healthy Volunteers