Functional Significance of Complexity Measures in the Sensory-motor Behavior

Healthy Volunteers Clinical Trial

— NEURO COMP  

Official title:

Functional Significance of Complexity Measures in the Sensory-motor Behavior: Are There Potential Clinical Applications?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610647
• Other study ID #: LOCAL/2014/ADKT-001
• Secondary ID: 2014-A01257-40
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: January 2, 2018
• Start date: June 6, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare between groups the level of complexity of the estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.

Description:

The secondary objectives of this study are to compare the level of complexity of the estimated sensorimotor performance using the(A) mono-fractal exhibitors (the αDFA values) and the (B) coefficient of variation (CV) between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• The subject does not practice music intensively (<1h / day on average)

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, or under guardianship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• The patient is pregnant, parturient, or breastfeeding

• The subject regularly practices music

• The subject is suffering from a neurodegenerative disease of the central or peripheral nervous system which may affect the sensorimotor control of rhythmic movements of the upper limb

• The subject has had a recent trauma of the upper limb

• The subject is suffering from uncorrected visual and hearing impairment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Wrist anesthesia
Prior to the tapping test, regional anesthesia is performed in the form of sensory blocks distal to the wrist: injection of ropivacaine 7.5mg / ml is carried out successively in contact with three nerves (ulnar, median and radial) with a volume of 2 ml for nerve, for a total of 45mg.

Other:
• Blinding mask
Patients will don a mask that prevents them from seeing during the tapping test.
• Anti-noise helmet
Patients will don a helmet that prevents them from hearing during the tapping test.
• Tapping test
Subjects will be placed at a table in a sitting position where they will perform a rhythmic finger tapping test. The seat height is adjusted so that the front dominant arm rests comfortably on the table. Subjects will be equipped with headphones to receive auditory signals during a first synchronized phase of tapping. After the last auditory signal, participants will continue the tapping task by themselves as directed: "after the metronome stops,continue tapping the prescribed tempo as accurately and consistently as possible throughout the test." The movements of the index finger will be measured by a single-axis accelerometer (15 × 15 mm) attached to the nail.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	minmaxMF-DFA value during the tapping test	The level of complexity of the estimated sensorimotor performance as measured by the multi-fractal exponents.	Day 0
Secondary	Coefficient of variation		Day 0
Secondary	aDFA value during the tapping test	The level of complexity of the estimated sensorimotor performance as measured by the single-fractal exponent.	Day 0