- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02597374
EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE) (AOE)
July 27, 2022 updated by: University Hospital, Angers
Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur. " Action-Observation-EEG "
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NGUYEN THE TICH Sylvie, MD-PHD
- Phone Number: 0033 2-41-35-44-45
- Email: sylvie.nguyenthe@gmail.com
Study Contact Backup
- Name: DINOMAIS Mickaël, MD-PHD
- Phone Number: 0033 2-41-35-18-03
- Email: mdinomais@les-capucins-angers.fr
Study Locations
-
-
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Angers, France, 49933
- Recruiting
- CHU Angers
-
Contact:
- MICKAEL DINOMAIS, MD-PHD
- Phone Number: 02 41 35 18 03
- Email: mdinomais@les-capucins-angers.fr
-
Contact:
- MAXIMILIEN PERIVIER
- Email: maxperivier@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unilateral cerebral injury
- hemiplegia
Exclusion Criteria:
- visual or mental or cognitive impairment
- no health insurance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
A 45 mn EEG for all the participants.
|
A 45 mn EEG will be performed in each participants during action and action observation of each hand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change measures of mu rhythm desynchronization (i.e. alpha band power) before the action execution or action observation and after the action execution or action observation
Time Frame: one day
|
The mu rhythm is a spontaneous sensorimotor rhythm made of neurophysiological oscillations with a frequency between 8 herz and 13 herz (alpha band), beside the sensorimotor cortex.
The alpha band is recorded on surface electroencephalography (EEG).
The power is the square of the amplitude of the spontaneous oscillations.
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: NGUYEN THE TICH Sylvie, MD-PHD, University Hospital, Angers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
October 22, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 5, 2015
Study Record Updates
Last Update Posted (Actual)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-Promoteur 2015-A00985-44
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.