Functional Significance of Complexity Measures in the Sensory-motor Behavior

NCT02610647 | Completed

• 2 other identifiers: LOCAL/2014/ADKT-0012014-A01257-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Coefficient of variation

  Day 0

• αDFA value during the tapping test

  Day 0

Study Arms (5)

Control group

OTHER

Subjects randomized to this group will have a tapping test with no sensory blocking. Intervention: Tapping test

Other: Tapping test

Wrist anesthesia

EXPERIMENTAL

Subjects randomized to this group will have an axillary block / regional anesthesia followed by a tapping test. Intervention: Wrist anesthesia Intervention: Tapping test

Drug: Wrist anesthesia; Other: Tapping test

Wrist anesthesia, masked

EXPERIMENTAL

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

Drug: Wrist anesthesia; Other: Blinding mask; Other: Tapping test

Wrist anesthesia, helmet

EXPERIMENTAL

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

Drug: Wrist anesthesia; Other: Anti-noise helmet; Other: Tapping test

Wrist anesthesia, masked & helmet

EXPERIMENTAL

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

Drug: Wrist anesthesia; Other: Blinding mask; Other: Anti-noise helmet; Other: Tapping test

Interventions

Wrist anesthesia DRUG

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.

Wrist anesthesia; Wrist anesthesia, helmet; Wrist anesthesia, masked; Wrist anesthesia, masked & helmet

Blinding mask OTHER

Patients will don a mask that prevents them from seeing during the tapping test.

Wrist anesthesia, masked; Wrist anesthesia, masked & helmet

Anti-noise helmet OTHER

Patients will don a helmet that prevents them from hearing during the tapping test.

Wrist anesthesia, helmet; Wrist anesthesia, masked & helmet

Tapping test OTHER

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.

Control group; Wrist anesthesia; Wrist anesthesia, helmet; Wrist anesthesia, masked; Wrist anesthesia, masked & helmet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1

Montpellier, 34090, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Torre K, Vergotte G, Viel E, Perrey S, Dupeyron A. Fractal properties in sensorimotor variability unveil internal adaptations of the organism before symptomatic functional decline. Sci Rep. 2019 Oct 31;9(1):15736. doi: 10.1038/s41598-019-52091-y.

  PMID: 31673034 RESULT

Study Officials

• Kjerstin Torre, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: June 6, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: November 19, 2025

Record last verified: 2018-01

Locations

FR (3)