Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

NCT01849822 | Completed Results DMC

• 1 other identifier: 16384
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Tetraplegia

Keywords

neural; prosthetic; brain machine interface; brain computer interface; brain control; paralysis; tetraplegia; quadriplegia; spinal cord injury

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Patient Control Over the End Effector (Virtual or Physical)

  The primary effectiveness objective of this study is to evaluate the effectiveness of the NPS in controlling virtual or physical end effectors. The driving hypotheses are that control over the physical and virtual end effectors, as measured by accuracy, will be significantly greater than the level of chance. Three methods will be used to assess the effectiveness of the extracorporeal device: standardized tests, comparison of task performance to the level of chance, and the Quality-of-Life Inventory (QOLI). In collaboration with therapists at Rancho Los Amigos National Rehabilitation Center, two commonly-used, standard tests have been selected by which the use of robotic arm will be evaluated: the Action Research Arm Test (ARAT) and the Canadian Occupational Performance Measure (COPM).

  Six years after array implantation

• Number of Participants With Absence of Infection or Irritation

  The primary objective of this study is to evaluate the safety of the NPS. The driving hypotheses are that the implantation will not be associated with infection or irritation, and that the serious adverse event rate will not rise above 1%. The method of evaluation will be inspection of subject'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 neuro exam. The SAE rate will be calculated as the number of SAEs per implant days.

  Six years after array implantation

Study Arms (1)

Neural Prosthetic System

EXPERIMENTAL

The Neural Prosthetic System consists of two Neuroport Arrays, which are described in detail in the intervention description. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.

Device: Neural Prosthetic System

Interventions

Neural Prosthetic System DEVICE

The Neural Prosthetic System is primarily composed of two NeuroPort Arrays. Each array is comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm 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. Each microelectrode has a platinum tip that is 100-200 microns in length and offers impedance values from 100-800 kilo-ohms. Of the 100 electrodes, 96 are wire bonded using 25 micron gold alloy insulated wires collectively sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the printed 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.

Also known as: NeuroPort Array

Neural Prosthetic System

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard A. Andersen, PhD: lead
• University of Southern California: collaborator
• Rancho Los Amigos National Rehabilitation Center: collaborator

Study Sites (3)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

California Institute of Technology

Pasadena, California, 91125, United States

Location

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

• 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.

  PMID: 31042684 DERIVED

Related Links

• Related Info

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

Results Point of Contact

• Title: Dr. Richard Andersen
• Organization: California Institute of Technology

andersen@vis.caltech.edu

16263958336

Study Officials

• Richard A Andersen, PhD

  California Institute of Technology

  PRINCIPAL INVESTIGATOR

• Charles Liu, MD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Christi Heck, MD, PhD, MMM

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Mindy Aisen, MD

  Rancho Los Amigos National Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: April 25, 2013
• First Posted: May 9, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 30, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-04

Locations

US (3)