Brain Implant for Neural Control of a Computer
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 22 - 65 |
| Updated: | 7/19/2018 |
| Start Date: | October 2013 |
| End Date: | December 2020 |
| Contact: | Nader Pouratian, MD, PhD |
| Email: | NPouratian@mednet.ucla.edu |
| Phone: | 310-206-2189 |
Feasibility Study for Use of a Brain Implant for Neural Control of a Computer
The investigators objective is to run human clinical trials in which brain activity recorded
through a "brain-chip" implanted in the human brain can be used to provide novel
communication capabilities to severely paralyzed individuals by allowing direct brain-control
of a computer interface. A prospective, longitudinal, single-arm early feasibility study will
be used to examine the safety and effectiveness of using a neural communication system to
control a simple computer interface and a tablet computer. Initial brain control training
will occur in simplified computer environments, however, the ultimate objective of the
clinical trial is to allow the human patient autonomous control over the Google Android
tablet operating system. Tablet computers offer a balance of ease of use and functionality
that should facilitate fusion with the BMI. The tablet interface could potentially allow the
patient population to make a phone call, manage personal finances, watch movies, paint
pictures, play videogames, program applications, and interact with a variety of "smart"
devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic
limbs and smart cars. Brain control of tablet computers has the potential to greatly improve
the quality of life of severely paralyzed individuals. Two subjects will be enrolled, each
implanted with the NCS for a period of 53 weeks. The study is expected to take two years in
total.
through a "brain-chip" implanted in the human brain can be used to provide novel
communication capabilities to severely paralyzed individuals by allowing direct brain-control
of a computer interface. A prospective, longitudinal, single-arm early feasibility study will
be used to examine the safety and effectiveness of using a neural communication system to
control a simple computer interface and a tablet computer. Initial brain control training
will occur in simplified computer environments, however, the ultimate objective of the
clinical trial is to allow the human patient autonomous control over the Google Android
tablet operating system. Tablet computers offer a balance of ease of use and functionality
that should facilitate fusion with the BMI. The tablet interface could potentially allow the
patient population to make a phone call, manage personal finances, watch movies, paint
pictures, play videogames, program applications, and interact with a variety of "smart"
devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic
limbs and smart cars. Brain control of tablet computers has the potential to greatly improve
the quality of life of severely paralyzed individuals. Two subjects will be enrolled, each
implanted with the NCS for a period of 53 weeks. The study is expected to take two years in
total.
Inclusion Criteria:
- High cervical spinal lesion
- Age 22-65 years
- Able to provide informed consent
- Able to understand and comply with instructions in English
- Able to communicate via speech
- Surgical clearance
- Life expectancy greater than 12 months
- Live within 60 miles of study location and willing to travel up to 5 days per week
- A regular caregiver to monitor the surgical site
- Psychosocial support system
- Ventilator independent
Exclusion Criteria:
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if
untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
- Scalp lesions or skin breakdown
- HIV or AIDS infection
- Active cancer or chemotherapy
- Diabetes
- Autonomic dysreflexia
- History of seizure
- Implanted hydrocephalus shunt
- History of supratentorial brain injury or neurosurgery
- Medical conditions contraindicating surgery and chronic implantation of a medical
device
- Unable to undergo MRI or anticipated need for MRI during study
- Nursing an infant or unwilling to bottle-feed infant
- Chronic oral or intravenous use of steroids or immunosuppressive therapy
- Suicidal ideation
- Drug or alcohol dependence
- Planning to become pregnant, or unwilling to use adequate birth control
- Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord
stimulator.
We found this trial at
3
sites
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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