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TetraplegiaNCT01849822

Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

A study testing Neural Prosthetic System in people with Tetraplegia, run by Richard A. Andersen, PhD at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tetraplegia
What is being tested?
Neural Prosthetic System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
3 sitesUnited States
Study dates
Feb 2013to Jan 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • Presence of memory problems
  • intellectual impairment
  • Psychotic illness or chronic psychiatric disorder, including major depression
  • Poor visual acuity
  • Pregnancy
  • Active infection or unexplained fever
Show all 22Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

  • University of Southern California

    Los Angeles, California, 90033

  • California Institute of Technology

    Pasadena, California, 91125

Other trials in United States

About this study

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

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.

Read more

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
Being tested
Neural Prosthetic System
Keywords
neural, prosthetic, brain machine interface, brain computer interface, brain control, paralysis, tetraplegia, quadriplegia, spinal cord injury
Medical subject headings
Quadriplegia, Paralysis, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neural Prosthetic SystemDevice

    Also called NeuroPort Array

    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.

Study groups in NCT01849822
Study groupRoleWhat they receive
Neural Prosthetic SystemExperimentalThe 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.
Receives: Device: Neural Prosthetic System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Six years after array implantation

  2. 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.

    Measured: Six years after array implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849822
Sponsor's protocol ID
16384
Status last verified
Apr 2021
First submitted
25 Apr 2013
Last updated
30 Apr 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39134021

  • 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.

    PubMed 31042684

Questions about this trial

What is this clinical trial studying?

A study testing Neural Prosthetic System in people with Tetraplegia, run by Richard A. Andersen, PhD at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Patient Control Over the End Effector (Virtual or Physical) (time frame: Six years after array implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849822, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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