Establishing Muscle Impedance Parameters With Electrical Impedance Myography

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 46 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study population: Individuals with IBM compared with age and sex matched people of typical health with: no active neuromuscular disorders or known history of neuromuscular disorders; no sign or symptoms of muscle weakness; no family history of muscular dystrophies or ALS. .

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)

Conditions

IBM, Inclusion Body Myositis

Being tested

electrical impedance myography (EIM)

Keywords

electrical impedance myography, EIM

Medical subject headings

Myositis, Inclusion Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• electrical impedance myography (EIM)Device

  EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. IBM-Functional Rating Scale

   Physical functioning in daily life will be measured using the IBM-Functional rating scale (IBM-FRS). IBM-FRS will be obtained for both IBM participants and healthy controls.

   Measured: 45 Minutes

2. Grip Strength

   Grip strength will be assessed using the Jamar hand dynamometer and will be obtained by the physician from both IBM participants and healthy controls. The best of three attempts will be used.

   Measured: 45 Minutes

3. Time to Stand

   Time to stand will be measured using the "Get-up-and-go test". Time will be measured for a participant to stand up from a chair (using arms if necessary), walk 3 meters, turn around, return to the chair, and sit down. The better of two trials will be used. These results will be obtained by the physician from both IBM participants and healthy controls.

   Measured: 45 Minutes

4. Walking Distance

   Distance walked by a participant in 6 minutes will be measured. Given the general disability of many IBM participants, rather than utilizing two trials, a 2-minute "practice" walk will be performed before the actual test, to familiarize the participant with the task to be performed. Both IBM participants and healthy controls will undergo this procedure.

   Measured: 45 Minutes

5. Manual Muscle Testing (MMT) Global Score

   This is a hands-on assessment that will use the Medical Research Council muscle scales (MRC) to score the strength of the following muscle groups that may be involved in IBM: neck flexor, extensor, deltoid, biceps, triceps, wrist extensor, wrist flexors, finger long and short flexors, finger extensors, hip flexors, hip adductors, hip abductors, knee extensors, knee flexors, ankle dorsi and planti flexors. MRC scores will be obtained by the physician from both IBM participants and healthy controls. A global score can be calculated and will be used. 0 (none) = no contraction, 1 (trace) = visible contraction with no motion, 2 (poor) = full range of motion, gravity eliminated, 3 (fair) = full range of motion against gravity, 4 (good) = full range of motion against gravity, moderate resistance, 5 (normal) = full range of motion against gravity, maximum resistance.

   Measured: 45 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Aug 2018
2. Study start19 Jun 2018
3. Primary completion30 Jun 2019
4. Study completion30 Jun 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for IBMStudies of the same condition, open and under way.
• More trials run by Yale UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.