Brain Tumors Clinical Trial
— BRAIN-TIMEOfficial title:
Localizing in the Brain the Areas of Time to Contact Perception During an Awake Surgery
During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: For the patients: - Brain tumor that does not affect the dominant hand motricity. The patient that have a tumor in an area targeted for a cortical stimulation will be automatically enrolled within the Pre-End group. - Who will agree with all terms and sign the experimental agreement - Correct or corrected vision, as allowed by the surgery constraints - With no known oculomotor abnormalities (list of exclusion in Annexe) - Affiliated to a social security system For the control group: - Who will agree with all terms and sign the experimental agreement - Correct or corrected vision - With no known oculomotor abnormalities. - Affiliated to a social security system Exclusion Criteria: For the patients: - Brain tumor located in the occipital area - Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team. - Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke - Pregnancy For the control group: - Legally protected patient, or with unknown ability to sign the experimental agreement, as determined by the medical team. - Medical background of neurological diseases of the central nervous system, as Parkinson, Alzheimer, stroke - Pregnancy |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral mapping | Look at how the cognitive functions of perception of time before contact are attached to brain structures, their communication with other zones, their alteration due to brain tumors for patients with a brain tumor compared to control subjects. The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event.
Brain mapping will be done through neurological examinations which are questionnaires and a risk-free task. All the tasks and all the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome. |
61 months | |
Secondary | Look the implication of other brain areas | Look to see if brain areas other than those targeted for stimulation in awake surgery are stimulated and therefore play a role in estimating time to contact.The treatment of the study being an awakened awakening as part of the routine care, there is no risk of serious adverse event.
Other brain areas will be define through neurological examinations which are questionnaires and a risk-free task. All the tasks and the questionnaires described in the paragraph "arm and intervention" will make it possible to meet this outcome. |
61 months |
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