Phenotypic Exploration During Sensory Stimulation in an Acoustic Chamber
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne
About this trial
An observational behavioural and neurophysiological study of the effects of controlled sensory stimulation (such as music, for example) on brain function
Eligibility criteria
This trial accepts healthy volunteersQualifiers
For patients : epilepsy
For healthy volunteers: age > 18 yo
Disqualifiers
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
Trial population
GHU paris Sainte Anne
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
320 Participants
are grouped into 1 trial groupGroup A: Epilepsy and music
Trial outcomes
Primary outcomes
1
Neuronal networks
Description of the neural networks involved during exposure to sensory stimuli
Time frame
All along the study (8 years)Secondary outcomes
1
Psychologic outcome : anxiety
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
Time frame
8 years2
Psychologic outcome 2 : depression
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
Time frame
8 years3
Quality of life measure
Assessment of the QOLIE-31(quality of life in epilepsy) scale among exposed patients
Time frame
8 yearsSponsors and contacts
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Source ClinicalTrials.gov