Clinical trial · Interventional
Picture Naming Decoding From Intraoperative Recordings
Picture Naming Decoding From Intraoperative Electrophysiological Recordings During Awake Brain Tumor Surgery.
NCT07499479CI-TRIAL-00106745Naming-Decodernot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placement of high-density electrodes on cortical surface during awake surgery | Procedure | — | UNRESOLVED |
| Placement of INBRAIN Graphene Cortical Interface on cortical surface | Procedure | — | UNRESOLVED |
| Placement of low-density electodes during awake brain surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )
- description
- 10 patients receive high-density electrodes.
- interventionNames
- Procedure: Placement of high-density electrodes on cortical surface during awake surgery
- Procedure: Placement of INBRAIN Graphene Cortical Interface on cortical surface
- type
- ACTIVE_COMPARATOR
- label
- DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III)
- description
- 10 patients receive strandard low-density electrodes.
- interventionNames
- Procedure: Placement of low-density electodes during awake brain surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 18 years of age or older. 2. 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. Exclusion Criteria: 1. Patients with severe cognitive impairments that would prevent understanding and performing the image-naming task, 2. Patients with major psychiatric disorders that could affect their ability to participate in the research, 3. Patients with inoperable tumors, 4. Patients with tumor locations incompatible with safe or effective placement of ECoG electrodes, 5. Females that are breastfeeding or females with childbearing potential with positive urine pregnancy test or not using adequate contraception, 6. Patients unable to provide informed consent due to cognitive or language limitations, 7. 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), 8. Any wearable medical device that may cause troubles to the investigational devices and injuries to the participants, 9. Patients with medical contraindications to general or local anesthesia required for surgery, 10. Patients with an active infection or infectious skin lesions on the scalp, 11. 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), 12. Patients with contraindications to any surgical procedure, 13. Patients undergoing treatment with anticoagulants, platelet aggregation inhibitors, or non-steroidal anti-inflammatory drugs, 14. Patients who decline to participate in the study, 15. 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, 16. Participation in another interventional study or being in the exclusion period at the end of a previous study.
References
Publications (0)
Data not yet available
No reference posted for this study.