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

Locked-In Syndrome Clinical Trial

— UNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224469
• Other study ID #: UMCU 12-370
• Secondary ID: STW 12803
• Status: Completed
• Phase: N/A
• Start date: September 9, 2015
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Locked-In Syndrome

Intervention

Device:
• ECoG (electrocorticography) sensing
Implant electrodes and sensing device and use for control of Assistive Technology

Locations

Country	Name	City	State
Netherlands	University Medical Center	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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 A — View 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: 1 — View 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 Neurop — View 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. 2 — View 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 — View 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. — View 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. — View 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 Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	supervised BCI performance	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
Primary	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	Patient Satisfaction	subjective ratings, hours use of BCI system per week, quality of life	up to 1 year

External Links

•   Info on research group
•   Related Info for laymen