Functional Significance of Complexity Measures in the Sensory-motor Behavior

NCT ID: NCT02610647

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control group

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

Intervention: Tapping test

Group Type OTHER

Tapping test

Intervention Type 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.

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

Group Type EXPERIMENTAL

Wrist anesthesia

Intervention Type 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.

Tapping test

Intervention Type 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.

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

Group Type EXPERIMENTAL

Wrist anesthesia

Intervention Type 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.

Blinding mask

Intervention Type OTHER

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

Tapping test

Intervention Type 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.

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

Group Type EXPERIMENTAL

Wrist anesthesia

Intervention Type 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.

Anti-noise helmet

Intervention Type OTHER

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

Tapping test

Intervention Type 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.

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

Group Type EXPERIMENTAL

Wrist anesthesia

Intervention Type 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.

Blinding mask

Intervention Type OTHER

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

Anti-noise helmet

Intervention Type OTHER

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

Tapping test

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Blinding mask

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

Intervention Type OTHER

Anti-noise helmet

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjerstin Torre, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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

Montpellier, , France

Site Status

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 31673034 (View on PubMed)

Other Identifiers

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2014-A01257-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/ADKT-001

Identifier Type: -

Identifier Source: org_study_id

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