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

February 14, 2024 updated by: Erik Aarnoutse, PhD, UMC Utrecht

Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584CX
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Activa PC + S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: up to 1 year
subjective ratings, hours use of BCI system per week, quality of life
up to 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Nick F Ramsey, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2015

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimated)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCU 12-370
  • STW 12803 (Other Grant/Funding Number: Technology Foundation STW)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

selected datasets will be available through a public repository after publication of results

IPD Sharing Time Frame

From Nov 14, 2016, no end date

IPD Sharing Access Criteria

According to http://datadryad.org/pages/policies

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: k9f10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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