Healthy VolunteerPROSCEANCT03182400
Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults
A study testing Neurophysiological assessment and Neuropsychological assessment in people with Healthy Volunteer, run by University Hospital, Tours at 1 site in France.
Trial summary
It is now widely accepted that autism is linked to a developmental disorder and cerebral function. Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and /… Read more about this study
- Who is it for?
- Ages 1 year to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Neurophysiological assessment and Neuropsychological assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2017to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between 1 and 60 years-old
- Able to understand and apply instructions for a task
- Information of subject or legal representant
- Informed written consent of subject or legal representant
- Affiliation to the social security system
Who cannot join
- Abnormal corrected vision
- Abnormal audition
- Known personal neurological pathology
- Known personal psychiatric problems
- Identified difficulties for walking, language, or learning
- Exclusion period because of participation to another experimental protocol
- Adult with legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chru Tours
Tours, 37044
Marie Gomot, 0247478664, gomot@univ-tours.fr
Frederique Bonnet-Brilhault, PhD
About this study
It is now widely accepted that autism is linked to a developmental disorder and cerebral function.
Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and / or visual information, could underly the symptoms observed in autism. A better knowledge of the typical development of the sensory and cognitive processes must therefore make it possible in the long term to identify the abnormalities linked to the autism spectrum disorders (ASD).
Read more
Studies in healthy subjects are therefore necessary in order to identify neurophysiological indices of cerebral functioning and to study their evolution during normal development, making it possible in the future to compare with populations of subjects with ASD.
The investigators intend to study the development of all the cognitive processes involved in the processing of sensory and, in particular, auditory and visual information in humans: from low-level perception processes to higher-level cognitive processes (attention, emotion, language, prediction, ...). For this the investigators will use non-invasive neurophysiological explorations (EEG, eye tracking) as well as neuropsychological explorations (Questionnaires or spontaneous language recording).
A better understanding of the pathophysiological mechanisms underlying the symptoms observed in autism could ultimately lead to the development of new specific therapeutic strategies, particularly in the field of exchange and development therapy or cognitive remediation .
- Conditions
- Healthy Volunteer
- Being tested
- Neurophysiological assessment, Neuropsychological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological assessmentBehavioural
Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments
Neuropsychological assessmentBehavioural
sub-tests, scales, surveys, reaction time measurement
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Neurophysiological assessment Neuropsychological assessment Receives: Behavioral: Neurophysiological assessment; Behavioral: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERP amplitude (µV)
analysis of ERP amplitude evoked during EEG recording
Measured: 1 hour
Secondary outcomes (2)
Reaction times (ms)
Reaction times collected during behavioral assessment
Measured: 1 hour
pupil size (mm)
pupil size measurements acquired with the eye tracker
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start14 Jun 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182400
- Sponsor's protocol ID
- PHAO17-FBB/PROSCEA
- Acronym
- PROSCEA
- Status last verified
- Sep 2022
- First submitted
- 23 May 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults
- ClinicalTrials.gov ID
- NCT03182400
- Acronym / sponsor ID
- PROSCEA / PHAO17-FBB/PROSCEA
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jun 2017 (actual)
- 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.
It is now widely accepted that autism is linked to a developmental disorder and cerebral function.
Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and / or visual information, could underly the symptoms observed in autism. A better knowledge of the typical development of the sensory and cognitive processes must therefore make it possible in the long term to identify the abnormalities linked to the autism spectrum disorders (ASD).
Studies in healthy subjects are therefore necessary in order to identify neurophysiological indices of cerebral functioning and to study their evolution during normal development, making it possible in the future to compare with populations of subjects with ASD.
The investigators intend to study the development of all the cognitive processes involved in the processing of sensory and, in particular, auditory and visual information in humans: from low-level perception processes to higher-level cognitive processes (attention, emotion, language, prediction, ...). For this the investigators will use non-invasive neurophysiological explorations (EEG, eye tracking) as well as neuropsychological explorations (Questionnaires or spontaneous language recording).
A better understanding of the pathophysiological mechanisms underlying the symptoms observed in autism could ultimately lead to the development of new specific therapeutic strategies, particularly in the field of exchange and development therapy or cognitive remediation .
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Behavioral: Neurophysiological assessment, Behavioral: Neuropsychological assessmentNeurophysiological assessment Neuropsychological assessment |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between 1 and 60 years-old
- Able to understand and apply instructions for a task
- Information of subject or legal representant
- Informed written consent of subject or legal representant
- Affiliation to the social security system
Key exclusion criteria (7 listed)
- Abnormal corrected vision
- Abnormal audition
- Known personal neurological pathology
- Known personal psychiatric problems
- Identified difficulties for walking, language, or learning
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 |
|---|---|---|
| Neurophysiological assessmentAssessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments | Behavioural | Healthy volunteer |
| Neuropsychological assessmentsub-tests, scales, surveys, reaction time measurement | Behavioural | Healthy volunteer |
Primary outcome
ERP amplitude (µV)
Time frame: 1 hour
analysis of ERP amplitude evoked during EEG recording
2 secondary outcomes
Reaction times (ms)
Time frame: 1 hour
pupil size (mm)
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological assessment and Neuropsychological assessment in people with Healthy Volunteer, run by University Hospital, Tours 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederique Bonnet-Brilhault, PhD (0247473846, f.bonnet-brilhault@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERP amplitude (µV) (time frame: 1 hour). 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 9 Sep 2022.