Healthy VolunteersNEURO COMPNCT02610647
Functional Significance of Complexity Measures in the Sensory-motor Behavior
A study testing Wrist anesthesia, Blinding mask and Anti-noise helmet in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Wrist anesthesia, Blinding mask and Anti-noise helmet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Jun 2017to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Laboratoire Movement to Health (M2H), Euromov, Université Montpellier 1
Montpellier, 34090
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Wrist anesthesia, Blinding mask, Anti-noise helmet, Tapping test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist anesthesiaDrug
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 maskOther
Patients will don a mask that prevents them from seeing during the tapping test.
Anti-noise helmetOther
Patients will don a helmet that prevents them from hearing during the tapping test.
Tapping testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Subjects randomized to this group will have a tapping test with no sensory blocking.
Intervention: Tapping test Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Wrist anesthesia; Other: Blinding mask; Other: Anti-noise helmet; Other: Tapping test |
What is being measured
The primary outcome is the main question the study is designed to answer.
minmaxMF-DFA value during the tapping test
The level of complexity of the estimated sensorimotor performance as measured by the multi-fractal exponents.
Measured: Day 0
Secondary outcomes (2)
Coefficient of variation
Measured: Day 0
αDFA value during the tapping test
The level of complexity of the estimated sensorimotor performance as measured by the single-fractal exponent.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start6 Jun 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjerstin Torre, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610647
- Sponsor's protocol ID
- LOCAL/2014/ADKT-001
- Other IDs
- 2014-A01257-40
- Acronym
- NEURO COMP
- Status last verified
- Jan 2018
- First submitted
- 18 Nov 2015
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31673034
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Significance of Complexity Measures in the Sensory-motor Behavior: Are There Potential Clinical Applications?
- ClinicalTrials.gov ID
- NCT02610647
- Acronym / sponsor ID
- NEURO COMP / LOCAL/2014/ADKT-001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Tapping testSubjects randomized to this group will have a tapping test with no sensory blocking. Intervention: Tapping test |
| Wrist anesthesia | Experimental | Drug: Wrist anesthesia, Other: Tapping testSubjects 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 | Experimental | Drug: Wrist anesthesia, Other: Blinding mask, Other: Tapping testSubjects 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 | Experimental | Drug: Wrist anesthesia, Other: Anti-noise helmet, Other: Tapping testSubjects 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 | Experimental | Drug: Wrist anesthesia, Other: Blinding mask, Other: Anti-noise helmet, Other: Tapping testSubjects 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist anesthesiaPrior 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. | Drug | Wrist anesthesia, Wrist anesthesia, helmet, Wrist anesthesia, masked, Wrist anesthesia, masked & helmet |
| Blinding maskPatients will don a mask that prevents them from seeing during the tapping test. | Other | Wrist anesthesia, masked, Wrist anesthesia, masked & helmet |
| Anti-noise helmetPatients will don a helmet that prevents them from hearing during the tapping test. | Other | Wrist anesthesia, helmet, Wrist anesthesia, masked & helmet |
| Tapping testSubjects 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. | Other | Control group, Wrist anesthesia, Wrist anesthesia, helmet, Wrist anesthesia, masked, Wrist anesthesia, masked & helmet |
Primary outcome
minmaxMF-DFA value during the tapping test
Time frame: Day 0
The level of complexity of the estimated sensorimotor performance as measured by the multi-fractal exponents.
2 secondary outcomes
Coefficient of variation
Time frame: Day 0
αDFA value during the tapping test
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 31673034Torre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjerstin Torre, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist anesthesia, Blinding mask and Anti-noise helmet in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minmaxMF-DFA value during the tapping test (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.