Clinical trial NCT01849822: Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia
Official title: A Feasibility Study of the Ability of the Neural Prosthetic System to Provide Direct Brain Control of Extracorporeal Devices in Patients With Quadriplegia Due to High Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetraplegia
Keywords: neural
prosthetic
brain machine interface
brain computer interface
brain control
paralysis
tetraplegia
quadriplegia
spinal cord injury
Lead sponsor: California Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Rancho Los Amigos National Rehabilitation Center
First posted: 2013-05-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research study is being done to develop a brain controlled medical device, called a brain-machine interface or BMI, that will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts.

Developing a brain-machine interface (BMI) is very difficult and currently only limited technology exists in this area of neuroscience. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.

The device being used in this study is called the NeuroPort Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One NeuroPort Array consists of a small grid of electrodes that will be implanted in brain tissue with a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude though the scalp to allow for connection with the computer equipment.

The investigators hope to learn how safe and effective the NeuroPort Array is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands. To accomplish this goal, two NeuroPort Arrays will be used.


Eligibility criteria: Inclusion Criteria:

* High cervical spinal lesion
* 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

Exclusion Criteria:

* Presence of memory problems
* intellectual impairment
* Psychotic illness or chronic psychiatric disorder, including major depression
* 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
* Previous neurosurgical history affecting parietal lobe function
* Medical conditions contraindicating surgery and chronic implantation of a medical device
* Prior cranioplasty
* 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

Primary outcomes:
measure: Number of Participants With Patient Control Over the End Effector (Virtual or Physical)
timeFrame: Six years after array implantation
measure: Number of Participants With Absence of Infection or Irritation
timeFrame: Six years after array implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Pasadena
country: United States
facility: California Institute of Technology
state: California
Study officials:
affiliation: California Institute of Technology
name: Richard A Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Charles Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Christi Heck, MD, PhD, MMM
role: PRINCIPAL_INVESTIGATOR
affiliation: Rancho Los Amigos National Rehabilitation Center
name: Mindy Aisen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saif-Ur-Rehman M, Lienkamper R, Parpaley Y, Wellmer J, Liu C, Lee B, Kellis S, Andersen R, Iossifidis I, Glasmachers T, Klaes C. SpikeDeeptector: a deep-learning based method for detection of neural spiking activity. J Neural Eng. 2019 Jul 23;16(5):056003. doi: 10.1088/1741-2552/ab1e63.