Visuomotor Prosthetic for Paralysis

NCT01958086 | Recruiting DMC

• 2 other identifiers: G12028713-000576
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

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. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.

Conditions

Quadriplegia

Keywords

Neural; Prosthetic; brain machine interface; brain computer interface; brain control; paralysis; tetraplegia; quadriplegia; spinal cord injury

Outcome Measures

Primary Outcomes (2)

• Subject control of a tablet computer

  Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.

  Six years after array implantation

• Absence of infection or irritation

  The Serious Adverse event (SAE) rate will be calculated as the number of SAEs per implant-days. The SAE rate will be continuously compared to the 1% threshold level. CT scan; inspection of patient's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms. Neurologic exam will be compared to baseline neurologic exam

  Six years after array implantation

Study Arms (1)

Neural Communication System

EXPERIMENTAL

The Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to use thought to control a simple computer environment or a tablet computer.

Device: Neural Communication System

Interventions

Neural Communication System DEVICE

NeuroPort Arrays allow for the local recording of cerebral cortex. The Neural Communication system is primarily composed of two NeuroPort Arrays. The two arrays of one MultiPort device will be placed in the primary motor cortex for recording (Platinum-tipped electrodes); and the two arrays of the additional MultiPort device be placed in the superior parietal lobule for recording (Platinum-tipped electrodes). Each MultiPort device consists of two arrays, each with 100 electrodes in a 10 x 10 configuration, with dimensions 4 mm x 4 mm x 1.5 mm (W x H x D) or 4 mm x 4 mm x 1.0 mm, and a titanium percutaneous connector, 19 mm diameter at the base. Each MultiPort can have a total of 128 active channels (capable of transmitting neural signals to the percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array.

Also known as: NeuroPort Multi-Port Array

Neural Communication System

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology resulting in paralysis
• Age 22-65 years
• Able to provide informed consent
• Understand and comply with instructions, if necessary, with the aid of a translator
• 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
• Stable ventilator status

You may not qualify if:

• 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
• Medically uncontrolled 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

Sponsors & Collaborators

• Richard A. Andersen, PhD: lead
• University of California, Los Angeles: collaborator
• Casa Colina Hospital and Centers for Healthcare: collaborator

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

California Institute of Technology

Pasadena, California, 91125, United States

RECRUITING

Casa Colina Centers for Rehabilitation

Pomona, California, 91769, United States

RECRUITING

Related Publications (2)

• Bashford L, Rosenthal IA, Kellis S, Bjanes D, Pejsa K, Brunton BW, Andersen RA. Neural subspaces of imagined movements in parietal cortex remain stable over several years in humans. J Neural Eng. 2024 Aug 28;21(4):046059. doi: 10.1088/1741-2552/ad6e19.

  PMID: 39134021 DERIVED

• Guan C, Aflalo T, Zhang CY, Amoruso E, Rosario ER, Pouratian N, Andersen RA. Stability of motor representations after paralysis. Elife. 2022 Sep 20;11:e74478. doi: 10.7554/eLife.74478.

  PMID: 36125116 DERIVED

MeSH Terms

Conditions

Quadriplegia; Paralysis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Richard A Andersen, PhD

  California Institute of Technology

  PRINCIPAL INVESTIGATOR

• Ausaf Bari, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Emily Rosario, PhD

  Casa Colina Hospital and Centers for Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ausaf Bari, MD, PhD

CONTACT

310-825-5111; ABari@mednet.ucla.edu

Emily Rosario, PhD

CONTACT

909.596.7733; ERosario@casacolina.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: James G. Boswell Professor of Neuroscience

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): July 31, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (3)