NCT05688683

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Jan 2023Mar 2028

Study Start

First participant enrolled

January 4, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

January 9, 2023

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • intracranial electroencephalography recording

    intracranial electroencephalography recording

    Day 0

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient benefiting from an intracranial brain recording during a programmed surgery for epilepsy or cerebral tumor resection in awake condition.

You may qualify if:

  • Benefiting from an intracranial brain recording during a programmed surgery in awake condition.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Adolphe de Rothschild

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Pierre Bourdillon, MD PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

January 4, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations