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

Not Applicable

Completed

• Conditions: Locked-In Syndrome
• Interventions: Device: ECoG (electrocorticography) sensing

• Registration Number: NCT02224469
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Study Start: 2015-09-09
• Status Verified: 2024-02
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECoG (electrocorticography) sensing	ECoG (electrocorticography) sensing	Use ECoG-based Brain Computer interface to control assistive technology

Primary Outcome Measures

Name	Time	Method
Unsupervised BCI performance	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

Name	Time	Method
Patient Satisfaction	up to 1 year	subjective ratings, hours use of BCI system per week, quality of life

Trial Locations

Locations (1)

University Medical Center; 🇳🇱 Utrecht, Netherlands