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

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ClinicalTrials.gov Identifier: NCT02224469
Recruitment Status : Recruiting
First Posted : August 25, 2014
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dr E. J. Aarnoutse, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE November 21, 2013
Estimated Primary Completion Date November 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02224469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
Patient Satisfaction [ Time Frame: up to 1 year ]
subjective ratings, hours use of BCI system per week, quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 22, 2014)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Official Title  ICMJE Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients
Brief Summary 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Locked-In Syndrome
Intervention  ICMJE Device: ECoG (electrocorticography) sensing
Implant electrodes and sensing device and use for control of Assistive Technology
Other Name: Activa PC + S
Study Arms  ICMJE Experimental: ECoG (electrocorticography) sensing
Use ECoG-based Brain Computer interface to control assistive technology
Intervention: Device: ECoG (electrocorticography) sensing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2014)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 21, 2021
Estimated Primary Completion Date November 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mariska J Vansteensel, PhD +31887555121 neuroprothese@umcutrecht.nl
Contact: Erik J Aarnoutse, PhD +31887555123 e.j.aarnoutse@umcutrecht.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224469
Other Study ID Numbers  ICMJE UMCU 12-370
STW 12803 ( Other Grant/Funding Number: Technology Foundation STW )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: selected datasets will be available through a public repository after publication of results
Time Frame: From Nov 14, 2016, no end date
Access Criteria: According to http://datadryad.org/pages/policies
URL: http://datadryad.org/resource/doi:10.5061/dryad.k9f10
Responsible Party Dr E. J. Aarnoutse, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nick F Ramsey, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP