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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Dr E. J. Aarnoutse, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02224469
First received: August 21, 2014
Last updated: August 22, 2014
Last verified: August 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 UMC Utrecht:

Primary Outcome Measures:
  • Unsupervised BCI performance [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    subjective ratings, hours use of BCI system per week, quality of life


Other Outcome Measures:
  • supervised BCI performance [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: August 21, 2014
Last Updated: August 22, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Dutch Health Care Inspectorate

Keywords provided by UMC Utrecht:
Brain-Computer Interface
Motor Cortex
Dorsolateral Prefrontal Cortex
Quality of Life

ClinicalTrials.gov processed this record on September 18, 2014