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

NCT ID: NCT02224469

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-09
• Study Completion Date: 2024-02-14

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).

Conditions

Locked-In Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ECoG (electrocorticography) sensing

Use ECoG-based Brain Computer interface to control assistive technology

Group Type: EXPERIMENTAL

ECoG (electrocorticography) sensing

Intervention Type: DEVICE

Implant electrodes and sensing device and use for control of Assistive Technology

Interventions

ECoG (electrocorticography) sensing

Implant electrodes and sensing device and use for control of Assistive Technology

Intervention Type: DEVICE

Other Intervention Names

Activa PC + S

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Erik Aarnoutse, PhD

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nick F Ramsey, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

University Medical Center

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 20517943 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22695047 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27959736 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31680806 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31401488 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28639486 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32963279 (View on PubMed)

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 Nov;155:1-15. doi: 10.1016/j.clinph.2023.08.003. Epub 2023 Aug 18.

Reference Type: RESULT

PMID: 37657190 (View on PubMed)

Vansteensel MJ, Leinders S, Branco MP, Crone NE, Denison T, Freudenburg ZV, Geukes SH, Gosselaar PH, Raemaekers M, Schippers A, Verberne M, Aarnoutse EJ, Ramsey NF. Longevity of a Brain-Computer Interface for Amyotrophic Lateral Sclerosis. N Engl J Med. 2024 Aug 15;391(7):619-626. doi: 10.1056/NEJMoa2314598.

Reference Type: RESULT

PMID: 39141854 (View on PubMed)

Leinders S, Aarnoutse EJ, Branco MP, Freudenburg ZV, Geukes SH, Schippers A, Verberne MSW, van den Boom M, van der Vijgh B, Crone NE, Denison T, Ramsey NF, Vansteensel MJ. DO NOT LOSE SLEEP OVER IT: IMPLANTED BRAIN-COMPUTER INTERFACE FUNCTIONALITY DURING NIGHTTIME IN LATE-STAGE AMYOTROPHIC LATERAL SCLEROSIS. medRxiv [Preprint]. 2024 Oct 15:2024.10.11.24315027. doi: 10.1101/2024.10.11.24315027.

Reference Type: DERIVED

PMID: 39484239 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Related Links

http://www.neuroprothese.nl

Related Info for laymen

http://www.nick-ramsey.eu

Info on research group

Other Identifiers

STW 12803

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UMCU 12-370

Identifier Type: -

Identifier Source: org_study_id