NCT02597374

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

8 years

First QC Date

October 22, 2015

Last Update Submit

July 27, 2022

Conditions

Cerebral PalsyChild

Keywords

Electroencephalographymu rhythmSensorimotor CortexUnilateral Cerebral PalsyChild

Outcome Measures

Primary Outcomes (1)

  • 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.

    one day

Study Arms (1)

Experimental

EXPERIMENTAL

A 45 mn EEG for all the participants.

Device: EEG

Interventions

EEGDEVICE

A 45 mn EEG will be performed in each participants during action and action observation of each hand.

Experimental

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • unilateral cerebral injury
  • hemiplegia

You may not qualify if:

  • visual or mental or cognitive impairment
  • no health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Angers

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • NGUYEN THE TICH Sylvie, MD-PHD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

NGUYEN THE TICH Sylvie, MD-PHD

CONTACT

2-41-35-44-45sylvie.nguyenthe@gmail.com

DINOMAIS Mickaël, MD-PHD

CONTACT

2-41-35-18-03mdinomais@les-capucins-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

November 5, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

FR(1)