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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Locked-In Syndrome

Intervention / Treatment
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* Device: ECoG (electrocorticography) sensing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECoG (electrocorticography) sensing<br>Use ECoG-based Brain Computer interface to control assistive technology | Device: ECoG (electrocorticography) sensing<br>* Implant electrodes and sensing device and use for control of Assistive Technology<br>* Other names: Activa PC + S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-Computer Interface, Motor Cortex, Dorsolateral Prefrontal Cortex, Quality of Life