Functional Significance of Complexity Measures in the Sensory-motor Behavior

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Wrist anesthesia; Other: Tapping test; Other: Blinding mask; Other: Anti-noise helmet

• Registration Number: NCT02610647
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2017-06-06
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wrist anesthesia	Tapping test	Subjects randomized to this group will have an axillary block / regional anesthesia followed by a tapping test. Intervention: Wrist anesthesia Intervention: Tapping test
Wrist anesthesia, masked	Blinding mask	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Tapping test
Wrist anesthesia, masked & helmet	Anti-noise helmet	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Anti-noise helmet Intervention: Tapping test
Control group	Tapping test	Subjects randomized to this group will have a tapping test with no sensory blocking. Intervention: Tapping test
Wrist anesthesia, helmet	Wrist anesthesia	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Anti-noise helmet Intervention: Tapping test
Wrist anesthesia, helmet	Anti-noise helmet	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Anti-noise helmet Intervention: Tapping test
Wrist anesthesia, masked & helmet	Blinding mask	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Anti-noise helmet Intervention: Tapping test
Wrist anesthesia	Wrist anesthesia	Subjects randomized to this group will have an axillary block / regional anesthesia followed by a tapping test. Intervention: Wrist anesthesia Intervention: Tapping test
Wrist anesthesia, masked	Wrist anesthesia	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Tapping test
Wrist anesthesia, masked	Tapping test	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Tapping test
Wrist anesthesia, helmet	Tapping test	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Anti-noise helmet Intervention: Tapping test
Wrist anesthesia, masked & helmet	Wrist anesthesia	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Anti-noise helmet Intervention: Tapping test
Wrist anesthesia, masked & helmet	Tapping test	Subjects randomized to this group will have an axillary block / regional anesthesia, will wear a blinding mask, will wear an anti-noise helmet, and then will perform a tapping test. Intervention: Wrist anesthesia Intervention: Blinding mask Intervention: Anti-noise helmet Intervention: Tapping test

Primary Outcome Measures

Name	Time	Method
minmaxMF-DFA value during the tapping test	Day 0	The level of complexity of the estimated sensorimotor performance as measured by the multi-fractal exponents.

Secondary Outcome Measures

Name	Time	Method
αDFA value during the tapping test	Day 0	The level of complexity of the estimated sensorimotor performance as measured by the single-fractal exponent.
Coefficient of variation	Day 0

Trial Locations

Locations (3)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1; 🇫🇷 Montpellier, France

CHU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France