Recruiting

Neuroport Array

Sponsor:

Richard A. Andersen, PhD

Code:

NCT01964261

Conditions

Quadriplegia

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Neural Prosthetic System 2 (NPS2)

Study Details

Brief summary:

This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device 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 along with sensory feedback.

Development of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. 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 and sense feeling in the hand and fingers. 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.

A key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and/or fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to "feel" what the robotic arm is touching.

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 and 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 through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.

The investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.

Conditions

Quadriplegia

Study ID

NCT01964261

Start date

Nov 1, 2013

Status verified date

May, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • High cervical spinal lesion
  • Age 22-65
  • Able to provide informed consent
  • Able to understand and comply with instructions in English
  • Communicate via speech
  • Surgical clearance
  • Life expectancy greater than 12 months
  • Travel up to 60 miles to study locations up to five days per week
  • Caregiver monitor for surgical site complications and behavioral changes on a daily basis
  • Psychosocial support system

Exclusion Criteria:

  • Presence of memory problems
  • 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
  • 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
  • Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
  • Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Neural Prosthetic System 2

The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. 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 control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.

Interventions

Neural Prosthetic System 2 (NPS2)

The NPS2 comprises 3 NeuroPort Arrays (SIROF). The tip of the electrodes are sputtered iridium oxide film (SIROF). Each array is comprised of 100 1.5 mm microelectrodes organized on a 4mm x 4mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Of the 100 electrodes, 96 are wire bonded using 25m gold alloy insulated wires sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface.

Primary outcome measure

  • Patient control over the end effector (virtual or physical) [ Time Frame: Nine years after array implantation ]
  • Absence of infection or irritation [ Time Frame: Nine years after array implantation ]

Central Contacts and Locations

Central contacts

Locations

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Charles Liu, MD, PhD

cliu@usc.edu

Richard Andersen

Recruiting

Pasadena, California, United States, 91125

Contacts

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

Richard A. Andersen, PhD

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • Neural
  • Prosthetic
  • Brain machine interface
  • brain computer interface
  • brain control
  • paralysis
  • tetraplegia
  • quadriplegia
  • spinal cord injury
  • stimulation
  • sensory feedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Richard A. Andersen, PhD on 2025-05-22.