MUNIX Variability in Healthy Subjects

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03593265
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: MUNIX	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Calculation of Normal MUNIX Variation in an Healthy Population
• Anticipated Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy group healthy subjects MUNIX will be performed	Other: MUNIX; Motor unit number index in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus

Outcome Measures

Primary Outcome Measures

1. MUNIX [3 months]

   motor unit number inedx in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus

Secondary Outcome Measures

1. MUSIX [3 months]

   muscle size index

2. CMAP amplitudes [3 months]

   the greatest possible amplitude

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca	France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: EMILIE GARRIDO PRADALIE, APHM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT03593265
• Other Study ID Numbers: 2018-45
• First Posted: Jul 20, 2018
• Last Update Posted: Jul 20, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 20, 2018