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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688683
Other study ID # PBN_2022_9
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2023
Est. completion date March 2028

Study information

Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Pierre Bourdillon, MD PHD
Phone +33 1 48 03 66 12
Email pbourdillon@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Interactions between the perceptual and motor systems are fundamental to the performance of complex motor tasks and are at the heart of the fine motor control required for the production of complex sounds such as speech production or playing a musical instrument. In such situations, the brain must learn to generate relevant motor commands to a sound-producing system with fixed physical characteristics, such as the vocal tract or a musical instrument. No study has yet been able to directly test the dynamic aspect of this sensorimotor learning in an acoustic production task with fine motor control. The Adolphe de Rothschild Foundation Hospital takes care of patients requiring awake surgery. During these procedures, a direct cortical recording, called electro-corticography, is performed in order to better delineate the tumor or epileptogenic resection area. Reference recordings are made in healthy areas at a distance from the lesion site making it possible to record normal brain activity. In this case, we would propose to the patient to use a tool similar to the theremin (a musical instrument the size of a golf ball whose displacement in space modulates the frequency and the harmonics of a sound). The patient should therefore learn in order to create relevant motor patterns.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 2028
Est. primary completion date March 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Benefiting from an intracranial brain recording during a programmed surgery in awake condition. Exclusion Criteria: - Patient with complete deafness - Patient with a disorder or impairment that does not allow him/her to perform the experimental task according to the investigator's judgment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
use of a theremin-type musical instrument
The patient will perform the task of reproducing sounds by manipulating an object. The settings of the object will be changed and the patient will have to reproduce the sounds a second time by manipulating the object.

Locations

Country Name City State
France Fondation Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary intracranial electroencephalography recording intracranial electroencephalography recording Day 0
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