|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02610647 |
|
Date of registration:
|
18/11/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Functional Significance of Complexity Measures in the Sensory-motor Behavior
NEURO COMP |
|
Scientific title:
|
Functional Significance of Complexity Measures in the Sensory-motor Behavior: Are There Potential Clinical Applications? |
|
Date of first enrolment:
|
June 6, 2017 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02610647 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Kjerstin Torre, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Centre Hospitalier Universitaire de Nîmes |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy Volunteers
|
|
Intervention(s)
|
|
Other: Tapping test
|
|
Drug: Wrist anesthesia
|
|
Other: Blinding mask
|
|
Other: Anti-noise helmet
|
|
Primary Outcome(s)
|
|
minmaxMF-DFA value during the tapping test
[Time Frame: Day 0]
|
|
Secondary Outcome(s)
|
|
Coefficient of variation
[Time Frame: Day 0]
|
|
aDFA value during the tapping test
[Time Frame: Day 0]
|
|
Secondary ID(s)
|
|
2014-A01257-40
|
|
LOCAL/2014/ADKT-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|