ECoG BMI for Motor and Speech Control

Официальное название

A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control

Обзор

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

Подробное описание

ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ECoG brain signals can be used to produce speech.

Вмешательства

• Устройство PMT/Blackrock Combination Device
  PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: Up to 6 years post-implant period]
• NIDCD Primary Objective 1 [Срок оценки: Up to 6 years post-implant period]
• NIDCD Primary Objective 2 [Срок оценки: Up to 6 years post-implant period]

Вторичные конечные точки (2)

• NIDCD Secondary Objective 1 [Срок оценки: Up to 6 years post-implant period]
• NIDCD Secondary Objective 2 [Срок оценки: Up to 6 years post-implant period]

Критерии участия

Критерии включения

• Age \> 21
• Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.
• Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living.
• If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
• Must live within a two-hour drive of UCSF

Критерии исключения

• Pregnancy or breastfeeding
• Inability to understand and/or read English
• Inability to give consent
• Dementia, based on history, physical exam, and MMSE
• Active depression (BDI \> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)
• History of suicide attempt or suicidal ideation
• History of substance abuse
• Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
• Inability to comply with study follow-up visits
• Any prior intracranial surgery
• History of seizures
• Immunocompromised
• Has an active infection
• Has a CSF drainage system or an active CSF leak
• Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
• Has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies
• Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of California San Francisco — San Francisco

Публикации

• Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler SC, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. J Neural Eng. 2025 Aug 7;22(4):046039. doi: 10.1088/1741-2552/adf50e. PMID 40720979
• Shah AM. Unlocking Naturalistic Speech With Brain-Computer Interface. Artif Organs. 2025 Jul;49(7):1087-1088. doi: 10.1111/aor.15021. Epub 2025 May 12. PMID 40353311
• Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler S, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. medRxiv [Preprint]. 2025 Apr 28:2025.04.24.25326368. doi: 10.1101/2025.04.24.25326368. PMID 40343020
• Metzger SL, Liu JR, Moses DA, Dougherty ME, Seaton MP, Littlejohn KT, Chartier J, Anumanchipalli GK, Tu-Chan A, Ganguly K, Chang EF. Generalizable spelling using a speech neuroprosthesis in an individual with severe limb and vocal paralysis. Nat Commun. 2022 Nov 8;13(1):6510. doi: 10.1038/s41467-022-33611-3. PMID 36347863
• Moses DA, Metzger SL, Liu JR, Anumanchipalli GK, Makin JG, Sun PF, Chartier J, Dougherty ME, Liu PM, Abrams GM, Tu-Chan A, Ganguly K, Chang EF. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. N Engl J Med. 2021 Jul 15;385(3):217-227. doi: 10.1056/NEJMoa2027540. PMID 34260835

Идентификаторы

NCT: NCT03698149 · 17-23028 · U01DC018671

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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