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EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE) (AOE)

Primary Purpose

Cerebral Palsy, Child

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring Electroencephalography, mu rhythm, Sensorimotor Cortex, Unilateral Cerebral Palsy, Child

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral cerebral injury
  • hemiplegia

Exclusion Criteria:

  • visual or mental or cognitive impairment
  • no health insurance

Sites / Locations

  • Chu AngersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

A 45 mn EEG for all the participants.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2015
Last Updated
July 27, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02597374
Brief Title
EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)
Acronym
AOE
Official Title
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 "
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Child
Keywords
Electroencephalography, mu rhythm, Sensorimotor Cortex, Unilateral Cerebral Palsy, Child

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
A 45 mn EEG for all the participants.
Intervention Type
Device
Intervention Name(s)
EEG
Intervention Description
A 45 mn EEG will be performed in each participants during action and action observation of each hand.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral cerebral injury hemiplegia Exclusion Criteria: visual or mental or cognitive impairment no health insurance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NGUYEN THE TICH Sylvie, MD-PHD
Phone
2-41-35-44-45
Ext
0033
Email
sylvie.nguyenthe@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DINOMAIS Mickaël, MD-PHD
Phone
2-41-35-18-03
Ext
0033
Email
mdinomais@les-capucins-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGUYEN THE TICH Sylvie, MD-PHD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICKAEL DINOMAIS, MD-PHD
Phone
02 41 35 18 03
Email
mdinomais@les-capucins-angers.fr
First Name & Middle Initial & Last Name & Degree
MAXIMILIEN PERIVIER
Email
maxperivier@gmail.com

12. IPD Sharing Statement

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EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)

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