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First Study With a Brain Implant to Help Locked-in Patients Communicate at Home (UNP)

This study is currently recruiting participants.
Verified November 2016 by Dr E. J. Aarnoutse, UMC Utrecht
Sponsor:
ClinicalTrials.gov Identifier:
NCT02224469
First Posted: August 25, 2014
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr E. J. Aarnoutse, UMC Utrecht
  Purpose
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

Condition Intervention
Locked-In Syndrome Device: ECoG (electrocorticography) sensing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients

Resource links provided by NLM:


Further study details as provided by Dr E. J. Aarnoutse, UMC Utrecht:

Primary Outcome Measures:
  • Unsupervised BCI performance [ Time Frame: up to 1 year ]
    The system correctly detects a switch brain signal within 10 sec in a real life, cognitively engaging context, such as operating a spelling device. A formal test has been designed, in which the patient has to copy a 30 character sentence within 30 minutes, with a margin of 20% faulty characters.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: up to 1 year ]
    subjective ratings, hours use of BCI system per week, quality of life


Other Outcome Measures:
  • supervised BCI performance [ Time Frame: up to 28 weeks ]
    The patient is able to generate switch commands with at least 80 % correct, with the help of a BCI researcher and/or caregiver (using a formal test)


Estimated Enrollment: 5
Study Start Date: November 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECoG (electrocorticography) sensing
Use ECoG-based Brain Computer interface to control assistive technology
Device: ECoG (electrocorticography) sensing
Implant electrodes and sensing device and use for control of Assistive Technology
Other Name: Activa PC + S

Detailed Description:
In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. The target population is people with locked-in syndrome. For these patients there is no technique available to allow them to communicate unaided. We have developed a brain-computer interface (BCI) system that can read activity directly from the brain, and can convert the activity to a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. A dedicated computer will convert the signals to electrical pulses for standard Assistive Technology devices. The UNP can in principle enable the patient to engage in any activity that is offered by commercial Assistive Technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. Most importantly, we aim to achieve unsupervised function of the BCI, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 75
  • Locked-in status (i.e. severely paralyzed with communication problems)

    • in case of trauma or stroke: at least 1 year after the event
    • in case of a neuromuscular disease: slow progression allowed
  • Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech)
  • Mentally and physically capable of giving informed consent
  • Lives in or close to the Netherlands
  • MR compatible

    • able to lie flat in the scanner
    • no metal objects in or attached to the body
    • no claustrophobia
  • Visus (largely) intact
  • Cognition intact (IQ>80)
  • Compatible with implantation procedure

    • good respiratory function or stable respiratory situation using ventilation assistance

Exclusion Criteria:

  • Strong and frequent spasms
  • Vital indication for blood thinners
  • Current brain tumor or history of tumor resection
  • Quick medical or neurological deterioration
  • Patients who are considered legally incapable (and who therefore will not be able to give informed consent)
  • Current or recent psychiatric disorder
  • Catabolic state
  • Allergy to the materials of the implant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224469


Contacts
Contact: Mariska J Vansteensel, PhD +31887555121 neuroprothese@umcutrecht.nl
Contact: Erik J Aarnoutse, PhD +31887555123 e.j.aarnoutse@umcutrecht.nl

Locations
Netherlands
University Medical Center Recruiting
Utrecht, Netherlands, 3584CX
Contact: Mariska J Vansteensel, PhD    +31887555121    neuroprothese@umcutrecht.nl   
Sub-Investigator: Erik J Aarnoutse, PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Nick F Ramsey, PhD UMC Utrecht
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr E. J. Aarnoutse, Study Coordinator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02224469     History of Changes
Other Study ID Numbers: UMCU 12-370
STW 12803 ( Other Grant/Funding Number: Technology Foundation STW )
First Submitted: August 21, 2014
First Posted: August 25, 2014
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: selected datasets will be available through a public repository after publication of results

Keywords provided by Dr E. J. Aarnoutse, UMC Utrecht:
Brain-Computer Interface
Motor Cortex
Dorsolateral Prefrontal Cortex
Quality of Life

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms