NCT03593265

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 10, 2018

Last Update Submit

July 10, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • MUNIX

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

    3 months

Secondary Outcomes (2)

  • MUSIX

    3 months

  • CMAP amplitudes

    3 months

Study Arms (1)

Healthy group

EXPERIMENTAL

healthy subjects MUNIX will be performed

Other: MUNIX

Interventions

MUNIXOTHER

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

Healthy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects without neuromuscular disoreders or others diseases which can interfer with MUNIX measurement
  • More than 18 years old

You may not qualify if:

  • Less than 18 years old
  • Diseases which can interfer with MUNIX measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

Study Officials

  • EMILIE GARRIDO PRADALIE

    APHM

    STUDY DIRECTOR

Central Study Contacts

EMILIEN DELMONT, MD

CONTACT

+33 4 91 38 49 46emilien.delmont@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

FR(1)