Functional Significance of Complexity Measures in the Sensory-motor Behavior (NEURO COMP)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Tapping test; Drug: Wrist anesthesia; Other: Blinding mask; Other: Anti-noise helmet

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Montpellier, France, 34090
    • Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Subjects randomized to this group will have a tapping test with no sensory blocking. Intervention: Tapping test	Other: 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.
Experimental: 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	Other: 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.; 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.
Experimental: Wrist anesthesia, masked; 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	Other: 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.; 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.
Experimental: Wrist anesthesia, 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	Other: 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.; 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: Anti-noise helmet; Patients will don a helmet that prevents them from hearing during the tapping test.
Experimental: Wrist anesthesia, masked & 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	Other: 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.; 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.; Other: Anti-noise helmet; Patients will don a helmet that prevents them from hearing during the tapping test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Kjerstin Torre, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: LOCAL/2014/ADKT-001; 2014-A01257-40 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No