- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544563
Phenotypic Exploration During Sensory Stimulation in an Acoustic Chamber (EMO-INTRA)
April 15, 2026 updated by: Centre Hospitalier St Anne
Exploration phénotypique en Contexte de Stimulations Sensorielles en Chambre Acoustique
An observational behavioural and neurophysiological study of the effects of controlled sensory stimulation (such as music, for example) on brain function
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
320
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: Viviane AWASSI
- Phone Number: +33145658486
- Email: v.awassi@ghu-paris.fr
Study Locations
-
-
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Paris, France, 75014
- Recruiting
- GHU Paris Sainte Anne
-
Contact:
- Estelle Pruvost-Robieux, MD, PHD
- Phone Number: +33145658189
- Email: e.pruvost@ghu-paris.fr
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Principal Investigator:
- Estelle Pruvost-Robieux, MD, PHD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
GHU paris Sainte Anne
Description
Inclusion Criteria:
- For patients : epilepsy
- For healthy volunteers: age > 18 yo
Exclusion Criteria:
- For patients and healthy volonteers : Deafness
- For healthy volunteers : History of neurological conditions (including stroke, coma, epilepsy, neuro-inflammatory or neurodegenerative disease) or diagnosed cognitive impairment
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Epilepsy and music
Epileptic patients (with or without mood disorders) exposed to music stimulations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuronal networks
Time Frame: All along the study (8 years)
|
Description of the neural networks involved during exposure to sensory stimuli
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All along the study (8 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychologic outcome : anxiety
Time Frame: 8 years
|
Assessment of the Generalized Anxiety Disorder-7 (GAD7) in the exposed patients across the hospitalization : minimum value 0; maximum 21; higher scores mean a worse outcome |
8 years
|
|
Psychologic outcome 2 : depression
Time Frame: 8 years
|
Assessment of the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in the exposed patients across the hospitalization : minimum value 6; maximum 24; higher scores mean a worse outcome
|
8 years
|
|
Quality of life measure
Time Frame: 8 years
|
Assessment of the QOLIE-31(quality of life in epilepsy) scale among exposed patients
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 2, 2025
Primary Completion (Estimated)
December 2, 2035
Study Completion (Estimated)
December 2, 2035
Study Registration Dates
First Submitted
April 3, 2026
First Submitted That Met QC Criteria
April 15, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D25-P008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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