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Brain-Computer Interface Implant for Severe Communication Disability

NCT04576650 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-11-07

No results posted yet for this study

Summary

Locked-In Syndrome (LIS) is a devastating condition in which a person has lost the ability to communicate due to motor impairment, while being mentally intact. For people affected by this severe communication impairment, Brain-Computer Interfaces (BCI) may be the only solution that allows these people to start a conversation, ask questions, or request assistance (i.e. self-initiated communication). To-date, spelling was accomplished at a rate of 2-3 letters per minute with a predecessor device (the Medtronic Activa PC+S). To improve BCI performance, the current protocol will use the Medtronic Summit System, which offers a rechargeable battery and improved signal quality relative to Activa PC+S. Using signals from the motor hand/arm and/or motor mouth/face area, the investigators will investigate different avenues to improve the speed of communication using the Summit System. The primary objective is to evaluate the safety of the Summit System when used to chronically record subdural electrocorticographic (ECoG) signals in a BCI for use by patients with LIS in patients' homes. The secondary objective will be to evaluate the efficacy of the Summit System as a long-term source of ECoG signals for a BCI capable of allowing participants to control alternative and augmentative communication software in patients' homes.

Conditions

  • Locked-in Syndrome

Interventions

DEVICE

Summit System

Surgical implantation of the Summit system (consisting of one or two Medtronic Activa(R) RC+S grids with wireless communication capabilities) for Safety and efficacy testing of the Medtronic Summit System.

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Nathan Crone, MD · Professor of Neurology, Johns Hopkins University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576650 on ClinicalTrials.gov