First Study With a Brain Implant to Help Locked-in Patients Communicate at Home (UNP)
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| ClinicalTrials.gov Identifier: NCT02224469 |
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Recruitment Status :
Completed
First Posted : August 25, 2014
Last Update Posted : February 15, 2024
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Sponsor:
UMC Utrecht
Information provided by (Responsible Party):
Erik Aarnoutse, PhD, UMC Utrecht
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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 |
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 (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 |
|---|---|
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Experimental: ECoG (electrocorticography) sensing
Use ECoG-based Brain Computer interface to control assistive technology
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Device: ECoG (electrocorticography) sensing
Implant electrodes and sensing device and use for control of Assistive Technology
Other Name: Activa PC + S |
Primary Outcome Measures :
- 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 :
- Patient Satisfaction [ Time Frame: up to 1 year ]subjective ratings, hours use of BCI system per week, quality of life
Other Outcome Measures:
- 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
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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 |
Criteria
Inclusion Criteria:
- Age 18 - 75
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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
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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)
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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 ClinicalTrials.gov identifier (NCT number): NCT02224469
Locations
| Netherlands | |
| University Medical Center | |
| Utrecht, Netherlands, 3584CX | |
Sponsors and Collaborators
UMC Utrecht
Investigators
| Principal Investigator: | Nick F Ramsey, PhD | UMC Utrecht |
Additional Information:
Study Data/Documents: Individual Participant Data Set
Publications of Results:
Other Publications:
Study Data/Documents: Individual Participant Data Set
Identifier: k9f10
Publications of Results:
Other Publications:
| Responsible Party: | Erik Aarnoutse, PhD, Study Coordinator, UMC Utrecht |
| ClinicalTrials.gov 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 http://datadryad.org/pages/policies |
| URL: | http://datadryad.org/resource/doi:10.5061/dryad.k9f10 |
Keywords provided by Erik Aarnoutse, PhD, UMC Utrecht:
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Brain-Computer Interface Motor Cortex Dorsolateral Prefrontal Cortex Quality of Life |
Additional relevant MeSH terms:
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Locked-In Syndrome Quadriplegia Paralysis |
Neurologic Manifestations Nervous System Diseases Neuromuscular Diseases |