Cerebral PalsyAOENCT02597374
EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)
A study testing EEG in people with Cerebral Palsy and Child, run by University Hospital, Angers at 1 site in France.
Trial summary
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Cerebral Palsy, Child
- What is being tested?
- EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2023
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- unilateral cerebral injury
- hemiplegia
Who cannot join
- visual or mental or cognitive impairment
- no health insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Angers
Angers, 49933
MICKAEL DINOMAIS, MD-PHD, 02 41 35 18 03, mdinomais@les-capucins-angers.fr
MAXIMILIEN PERIVIER, maxperivier@gmail.com
About this study
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 "
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.
- Conditions
- Cerebral Palsy, Child
- Being tested
- EEG
- Keywords
- Electroencephalography, mu rhythm, Sensorimotor Cortex, Unilateral Cerebral Palsy, Child
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
A 45 mn EEG will be performed in each participants during action and action observation of each hand.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | A 45 mn EEG for all the participants. Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- NGUYEN THE TICH Sylvie, MD-PHD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597374
- Sponsor's protocol ID
- CHU-Promoteur 2015-A00985-44
- Acronym
- AOE
- Status last verified
- Jul 2022
- First submitted
- 22 Oct 2015
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 "
- ClinicalTrials.gov ID
- NCT02597374
- Acronym / sponsor ID
- AOE / CHU-Promoteur 2015-A00985-44
- Conditions
- Cerebral Palsy, Child
- Keywords
- Electroencephalography, mu rhythm, Sensorimotor Cortex, Unilateral Cerebral Palsy, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 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.
To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: EEGA 45 mn EEG for all the participants. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- unilateral cerebral injury
- hemiplegia
Key exclusion criteria (2 listed)
- visual or mental or cognitive impairment
- no health insurance
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 |
|---|---|---|
| EEGA 45 mn EEG will be performed in each participants during action and action observation of each hand. | Device | Experimental |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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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.
NGUYEN THE TICH Sylvie, MD-PHD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG in people with Cerebral Palsy and Child, run by University Hospital, Angers at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NGUYEN THE TICH Sylvie, MD-PHD (2-41-35-44-45 ext. 0033, sylvie.nguyenthe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2022.