MUNIX Variability in Healthy Subjects | NCT03593265

Studies
MUNIX Variability in Healthy Subjects

NCT03593265

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Jul 20, 2018Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

MUNIX

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Jul 10, 2018

First Posted Date

Jul 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2018

Last Update Posted Date

Jul 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy group	Experimental	healthy subjects MUNIX will be performed	Other: MUNIX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MUNIX	Other	Motor unit number index in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus	Healthy group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MUNIX	motor unit number inedx in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus	3 months

Secondary Outcomes

Measure	Description	Time Frame
MUSIX	muscle size index	3 months
CMAP amplitudes	the greatest possible amplitude	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
EMILIEN DELMONT, MD	Contact	+33 4 91 38 49 46		emilien.delmont@ap-hm.fr

Overall Officials

Name	Affiliation	Role
EMILIE GARRIDO PRADALIE	APHM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Des Hopitaux de Marseille		Marseille	PACA	13354	France