Aphasia Following Cerebral Infarction, Aphasia Following Nontraumatic Intracerebral Hemorrhage, Aphasia Non Fluent, Expressive Aphasia
Conditions
Keywords
Brain-Computer Interface, BCI, Aphasia, Brain-Machine Interface, BrainGate, neuroprosthetic, Neuroport
Brief summary
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.
Detailed description
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment or aphasia, to recover a host of abilities that normally rely on the hands or on speech.
Interventions
Up to six 4x4 mm BrainGate sensor(s) are placed into the speech or language-related cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Sponsors
Leigh R. Hochberg, MD, PhD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (There are additional inclusion criteria)
Exclusion criteria
* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the BrainGate2 Neural Interface System | One year post-implant evaluation period | The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of speech decoding | One-year post implant evaluation period | The secondary endpoints of this Study are to investigate the feasibility of the BrainGate system and to establish the parameters for a larger clinical study, The main secondary endpoint is the ability of the system to decode neural signals related to speech / language generation into output for text- and/or speech- generating devices. |
Contacts
CONTACTLeigh R Hochberg, M.D., Ph.D.
CONTACTMaryam Masood, M.S.
STUDY_DIRECTORLeigh R Hochberg, MD, PhD
Massachusetts General Hospital
Outcome results
None listed