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

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. Read our disclaimer for details. Identifier: NCT02224469
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : February 15, 2024
Information provided by (Responsible Party):
Erik Aarnoutse, PhD, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Locked-In Syndrome Device: ECoG (electrocorticography) sensing Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
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
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : February 14, 2024
Actual Study Completion Date : February 14, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Other Outcome Measures:
  1. 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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT02224469

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University Medical Center
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Nick F Ramsey, PhD UMC Utrecht
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site
Identifier: k9f10

Publications of Results:

Other Publications:
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Responsible Party: Erik Aarnoutse, PhD, Study Coordinator, UMC Utrecht Identifier: NCT02224469    
Other Study ID Numbers: UMCU 12-370
STW 12803 ( Other Grant/Funding Number: Technology Foundation STW )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
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
Time Frame: From Nov 14, 2016, no end date
Access Criteria: According to
Keywords provided by Erik Aarnoutse, PhD, UMC Utrecht:
Brain-Computer Interface
Motor Cortex
Dorsolateral Prefrontal Cortex
Quality of Life
Additional relevant MeSH terms:
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Locked-In Syndrome
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases