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

Primary Purpose

Locked-In Syndrome

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ECoG (electrocorticography) sensing
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Locked-In Syndrome focused on measuring Brain-Computer Interface, Motor Cortex, Dorsolateral Prefrontal Cortex, Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECoG (electrocorticography) sensing

Arm Description

Use ECoG-based Brain Computer interface to control assistive technology

Outcomes

Primary Outcome Measures

Unsupervised BCI performance
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
subjective ratings, hours use of BCI system per week, quality of life

Full Information

First Posted
August 21, 2014
Last Updated
October 4, 2023
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT02224469
Brief Title
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Acronym
UNP
Official Title
Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2013 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locked-In Syndrome
Keywords
Brain-Computer Interface, Motor Cortex, Dorsolateral Prefrontal Cortex, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECoG (electrocorticography) sensing
Arm Type
Experimental
Arm Description
Use ECoG-based Brain Computer interface to control assistive technology
Intervention Type
Device
Intervention Name(s)
ECoG (electrocorticography) sensing
Other Intervention Name(s)
Activa PC + S
Intervention Description
Implant electrodes and sensing device and use for control of Assistive Technology
Primary Outcome Measure Information:
Title
Unsupervised BCI performance
Description
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.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
subjective ratings, hours use of BCI system per week, quality of life
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
supervised BCI performance
Description
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)
Time Frame
up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick F Ramsey, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://datadryad.org/resource/doi:10.5061/dryad.k9f10
Citations:
PubMed Identifier
20517943
Citation
Vansteensel MJ, Hermes D, Aarnoutse EJ, Bleichner MG, Schalk G, van Rijen PC, Leijten FS, Ramsey NF. Brain-computer interfacing based on cognitive control. Ann Neurol. 2010 Jun;67(6):809-16. doi: 10.1002/ana.21985.
Results Reference
background
PubMed Identifier
22695047
Citation
Torres Valderrama A, Paclik P, Vansteensel MJ, Aarnoutse EJ, Ramsey NF. Error probability of intracranial brain computer interfaces under non-task elicited brain states. Clin Neurophysiol. 2012 Dec;123(12):2392-401. doi: 10.1016/j.clinph.2012.05.006. Epub 2012 Jun 12.
Results Reference
background
PubMed Identifier
27959736
Citation
Vansteensel MJ, Pels EGM, Bleichner MG, Branco MP, Denison T, Freudenburg ZV, Gosselaar P, Leinders S, Ottens TH, Van Den Boom MA, Van Rijen PC, Aarnoutse EJ, Ramsey NF. Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS. N Engl J Med. 2016 Nov 24;375(21):2060-2066. doi: 10.1056/NEJMoa1608085. Epub 2016 Nov 12.
Results Reference
result
PubMed Identifier
31680806
Citation
Freudenburg ZV, Branco MP, Leinders S, van der Vijgh BH, Pels EGM, Denison T, van den Berg LH, Miller KJ, Aarnoutse EJ, Ramsey NF, Vansteensel MJ. Sensorimotor ECoG Signal Features for BCI Control: A Comparison Between People With Locked-In Syndrome and Able-Bodied Controls. Front Neurosci. 2019 Oct 16;13:1058. doi: 10.3389/fnins.2019.01058. eCollection 2019.
Results Reference
result
PubMed Identifier
31401488
Citation
Pels EGM, Aarnoutse EJ, Leinders S, Freudenburg ZV, Branco MP, van der Vijgh BH, Snijders TJ, Denison T, Vansteensel MJ, Ramsey NF. Stability of a chronic implanted brain-computer interface in late-stage amyotrophic lateral sclerosis. Clin Neurophysiol. 2019 Oct;130(10):1798-1803. doi: 10.1016/j.clinph.2019.07.020. Epub 2019 Jul 27.
Results Reference
result
PubMed Identifier
28639486
Citation
Pels EGM, Aarnoutse EJ, Ramsey NF, Vansteensel MJ. Estimated Prevalence of the Target Population for Brain-Computer Interface Neurotechnology in the Netherlands. Neurorehabil Neural Repair. 2017 Jul;31(7):677-685. doi: 10.1177/1545968317714577. Epub 2017 Jun 22.
Results Reference
result
PubMed Identifier
32963279
Citation
Leinders S, Vansteensel MJ, Branco MP, Freudenburg ZV, Pels EGM, Van der Vijgh B, Van Zandvoort MJE, Ramsey NF, Aarnoutse EJ. Dorsolateral prefrontal cortex-based control with an implanted brain-computer interface. Sci Rep. 2020 Sep 22;10(1):15448. doi: 10.1038/s41598-020-71774-5.
Results Reference
result
PubMed Identifier
37657190
Citation
Leinders S, Vansteensel MJ, Piantoni G, Branco MP, Freudenburg ZV, Gebbink TA, Pels EGM, Raemaekers MAH, Schippers A, Aarnoutse EJ, Ramsey NF. Using fMRI to localize target regions for implanted brain-computer interfaces in locked-in syndrome. Clin Neurophysiol. 2023 Aug 18;155:1-15. doi: 10.1016/j.clinph.2023.08.003. Online ahead of print.
Results Reference
result
Links:
URL
http://www.neuroprothese.nl
Description
Related Info for laymen
URL
http://www.nick-ramsey.eu
Description
Info on research group
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://datadryad.org/resource/doi:10.5061/dryad.k9f10
Available IPD/Information Identifier
k9f10

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

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