Visuomotor Prosthetic for Paralysis

ConditionQuadriplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorRichard A. Andersen, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Intellectual impairment

Psychotic illness or chronic psychiatric disorder, including major depression if untreated

Poor visual acuity

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

2 Participants
are divided into 1 treatment group
Group A: Neural Communication SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Six years after array implantation
2

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

Time frame
Six years after array implantation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Richard A. Andersen, PhD

Lead sponsor

California Institute of Technology

Sponsor institution

University of California, Los Angeles

Collaborator

Casa Colina Hospital and Centers for Healthcare

Collaborator