ECoG BMI for Motor and Speech Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2030-08-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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ALS SCI - Spinal Cord Injury Stroke Multiple Sclerosis Muscular Dystrophies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Electrocorticography-based brain computer interface

Group Type EXPERIMENTAL

PMT/Blackrock Combination Device

Intervention Type DEVICE

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Interventions

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PMT/Blackrock Combination Device

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age \> 21
2. 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.
3. 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.
4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
5. Must live within a two-hour drive of UCSF

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Inability to understand and/or read English
3. Inability to give consent
4. Dementia, based on history, physical exam, and MMSE
5. 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.)
6. History of suicide attempt or suicidal ideation
7. History of substance abuse
8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
9. Inability to comply with study follow-up visits
10. Any prior intracranial surgery
11. History of seizures
12. Immunocompromised
13. Has an active infection
14. Has a CSF drainage system or an active CSF leak
15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
16. 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
17. 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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No