Picture Naming Decoding From Intraoperative Recordings

Официальное название

Picture Naming Decoding From Intraoperative Electrophysiological Recordings During Awake Brain Tumor Surgery.

Обзор

The clinical investigation evaluates whether speech can be decoded from neural activity recorded with cortical surface electrocorticography (ECoG) electrodes during awake brain tumor surgery. Neural signals and voice recordings are collected while patients perform a picture naming task as part of standard intraoperative mapping. The study assesses the ability of machine learning algorithms to predict the named item from intraoperative electrophysiological recordings.

Подробное описание

Patients with severe speech and motor impairments often lose the ability to communicate, detrimentally affecting their quality of life. Invasive brain-computer interfaces (BCIs) have shown promise in restoring lost speech functionalities by decoding neural activity of intended or attempted speech. However, the systems with the most promising results rely on highly invasive micro-electrode arrays that tend to irritate the brain tissue leading to inflammation, tissue scarring and ultimately, loss of signal. A promising long-term alternative is intracranial electrode strips/grids that rest on the surface of the brain without having to penetrate the cortex. The contact density of standard strips/grids used for electrophysiological mapping is very low (1 contact/cm2 compared to 100 contacts/cm2), however, a new generation of electrode strips/grids offer decent contact density closing the distance with micro-electrode arrays. In order to determine if the contact density of cortical surface electrode grids is sufficient for decoding speech, we aim to record and decode neural activity of tumor patients performing a picture naming task during awake surgeries, as these operations offer the only opportunity to test the use of cortical surface electrodes for neural speech decoding.

Вмешательства

• Процедура Placement of high-density electrodes on cortical surface during awake surgery
  INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )high-density graphene ECoG grid placed on cortical surface for up to 2 hours during awake surgery. Recording only, no stimulation.
• Процедура Placement of INBRAIN Graphene Cortical Interface on cortical surface
  INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )high-density graphene ECoG grid placed on cortical surface for up to 2 hours during awake brain surgery. Recording only, no stimulation.
• Процедура Placement of low-density electodes during awake brain surgery
  DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III) low-density ECoG strips placed on cortical surface for up to 2 hours during awake surgery. Recording only, no stimulation.

Первичные конечные точки

• Primary outcome Measure [Срок оценки: Up to 12 months after the last patient's intraoperative recording]

Вторичные конечные точки (1)

• Secondary Outcome Measure [Срок оценки: Up to 12 months after the last patient's intraoperative recording]

Критерии участия

Критерии включения

• Patients 18 years of age or older.
• Patients with a brain tumor requiring surgery under "awake" conditions with intraoperative placement of ECoG electrodes at Lariboisière Hospital.

3 -Patients with tumor locations close to language processing areas. 4 -Patients having given consent during the interview with the neurosurgeon.

Критерии исключения

• Patients with severe cognitive impairments that would prevent understanding and performing the image-naming task,
• Patients with major psychiatric disorders that could affect their ability to participate in the research,
• Patients with inoperable tumors,
• Patients with tumor locations incompatible with safe or effective placement of ECoG electrodes,
• Females that are breastfeeding or females with childbearing potential with positive urine pregnancy test or not using adequate contraception,
• Patients unable to provide informed consent due to cognitive or language limitations,
• Patients who have any electrical stimulator or any active implanted medical device that uses high magnetic or electrical currents (e.g. patients with pacemaker defibrillator, neurostimulator, drugs pumps, retinal and cochlear device),
• Any wearable medical device that may cause troubles to the investigational devices and injuries to the participants,
• Patients with medical contraindications to general or local anesthesia required for surgery,
• Patients with an active infection or infectious skin lesions on the scalp,
• Patients with a current use or a recent history of illicit drug(s) use or alcohol abuse (defined as frequent or daily consumption of more than four alcoholic drinks per day),
• Patients with contraindications to any surgical procedure,
• Patients undergoing treatment with anticoagulants, platelet aggregation inhibitors, or non-steroidal anti-inflammatory drugs,
• Patients who decline to participate in the study,
• Any specially protected person: adults protected by law; persons hospitalized without their consent, at the request of a third party or ex officio; persons deprived of their liberty by a judicial decision,
• Participation in another interventional study or being in the exclusion period at the end of a previous study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Department of neurosurgery Lariboisière hospital-APHP — Paris

Идентификаторы

NCT: NCT07499479 · APHP 250697 · 2025-A00931-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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