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NCT03593265 Clinical Trial

MUNIX Variability in Healthy Subjects

Healthy Clinical Trial

— MUNIX  

Official title:
Calculation of Normal MUNIX Variation in an Healthy Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03593265
Other study ID # 2018-45
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2018
Est. completion date January 2020

Study information
Verified date July 2018
Source Assistance Publique Hopitaux De Marseille
Contact EMILIEN DELMONT, MD
Phone +33 4 91 38 49 46
Email emilien.delmont@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles : tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Description:

Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date January 2020
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy subjects without neuromuscular disoreders or others diseases which can interfer with MUNIX measurement

- More than 18 years old

Exclusion Criteria:

- Less than 18 years old

- Diseases which can interfer with MUNIX measurement

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• MUNIX
Motor unit number index in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus

Locations
Country Name City State
France Assistance Publique Des Hopitaux de Marseille Marseille Paca

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary MUNIX motor unit number inedx in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus 3 months
Secondary MUSIX muscle size index 3 months
Secondary CMAP amplitudes the greatest possible amplitude 3 months
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