Brain-Computer Interface Implant for Severe Communication Disability

NCT04576650 | Withdrawn DMC FDA Device

• 2 other identifiers: IRB00217299U01DC016686
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Safety of Summit System as assessed by the number of adverse events

  Record all adverse events on adverse events case report forms.

  Up to 52 weeks

• Safety of Summit System as assessed by change in neurological deficits

  Pre- and post-surgical neurological/neurosurgical examinations to assess neurological deficits.

  Immediately before device implantation, immediately after device implantation and 4-5 weeks after device implantation

• Safety of Summit System as assessed by the status of stimulation

  Verify that stimulation remains switched off (status is on or off).

  Up to 52 weeks

Secondary Outcomes (4)

• Efficacy of Summit System as assessed by change in letters spelled per minute

  Weekly up to 52 weeks

• Efficacy of Summit System as assessed by ability of participant to trigger the caregiver calling signal

  Up to 52 weeks

• Change in Quality of Life as assessed by the ACSA

  Every 12 weeks up to 52 weeks

• Frequency of use of Summit System per day

  Up to 52 weeks

Study Arms (1)

Summit system

EXPERIMENTAL

Implantation of Summit system, consisting of one or two Medtronic Activa(R) RC+S grids with wireless communication capabilities.

Device: Summit System

Interventions

Summit System DEVICE

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.

Summit system

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 22-75 years.

You may not qualify if:

• a. "Classic" Locked-In Syndrome, with the following signs documented on neurological examination i. Quadriplegia ii. Bulbar palsy iii. Anarthria iv. Partial or complete preservation of vertical eye movements and upper eyelid movements, or b. "Incomplete" Locked-In Syndrome, with the aforementioned signs of "Classic" LIS, documented on neurological examination, except that voluntary movements other than upper eyelid and vertical eye movement may be preserved, albeit still severe enough to prevent independent initiation and maintenance of communication, without the assistance of a caregiver. Preserved voluntary movements may include: i. Horizontal eye movements ii. Facial movements iii. Movements of the extremities not sufficient to reliably operate a joystick or mouse
• a. Permanent lesion of corticospinal and corticobulbar tracts in the ventral pons (basis pontis) due to ischemic stroke, hemorrhage, or trauma, based on the following: i. Documented history of acute ischemic or hemorrhagic brainstem stroke or traumatic brainstem injury at onset of LIS ii. Ancillary testing including the following:
• \. Brain MRI confirming a chronic lesion of the ventral pons, with no change on serial images at least 1 month apart, consistent with findings on neurological examination, involving at least 50% of the cross-sectional area on both sides of the basis pontis on at least one axial section 2. Absence of lesions on brain MRI that could contribute to communication impairment, including lesions of Broca's or Wernicke's areas, or sensorimotor cortex 3. EEG demonstrating posterior basic rhythm reactive to eye opening and closing iii. No clinical evidence of improving communication ability for at least 1 year prior to recruitment, confirming chronic LIS b. Diagnosis of Amyotrophic Lateral Sclerosis (ALS), certified by an independent board-certified neurologist with expertise in neuromuscular disorders, satisfying the following El Escorial World Federation of Neurology diagnostic criteria for probable, laboratory supported, or definite ALS: i. Signs of lower motor neuron (LMN) degeneration by neurological examination (weakness, atrophy, and fasciculations), electrophysiological (electromyographic findings of denervation), or neuropathological determination (muscle biopsy) in bulbar and at least two of three spinal regions (cervical, thoracic, lumbosacral), or in all three spinal regions ii. Signs of upper motor neuron (UMN) degeneration by clinical examination (spasticity, hyperreflexia, pseudobulbar affect, pathological reflexes) in bulbar and at least two of three spinal regions (cervical, thoracic, lumbosacral), or in all three spinal regions iii. Progressive spread of signs within a region or to other regions, together with the absence of electrophysiological or neuroimaging evidence of other disease processes that might explain clinical and electrophysiological signs of LMN and/or UMN degeneration (see below) iv. Confirmatory testing including:
• Electrophysiological Studies
• Electromyographic findings of denervation (reduced recruitment, large motor unit action potentials, and fibrillation potentials) in clinically involved regions, including 3 of the following 4 muscle regions: bulbar, cervical, thoracic, and lumbosacral
• Nerve conduction studies confirming absence of demyelination as an explanation for aforementioned LMN signs
• Neuroimaging, including brain and spine MRI, ruling out brain or spinal lesions (spinal cord or root compression) that could explain aforementioned LMN or UMN signs
• Clinical laboratory examinations, determined by clinical judgment, to ascertain possible ALS-related syndromes v. History, physical, and laboratory examinations ruling out alternative diagnoses as cause of aforementioned clinical syndrome, including monoclonal gammopathy, autoimmune motor system degeneration, hyperthyroidism, hyperparathyroidism, paraneoplastic syndrome, infections of the central nervous system, toxic-metabolic disorders, or spinal cord injury due to trauma, electric shock, radiation therapy, vasculitis, ischemia, hemorrhage, or spondylotic myelopathy vi. No clinical evidence for improving communication ability for at least 6 months, confirming chronic LIS
• Reliable means of communicating with caregiver(s) before entering the study, for example using vertical eye movements or eye blinking. Assessment of communication capabilities may be made by a physiatrist, a speech therapist, and/or an occupational therapist.
• Residence within a reasonable driving distance from the JHU research team
• Medically stable, including stable respiratory function, with or without artificial ventilation (see Section 12.2.3, Section 12.2.6, and Section 12.2.11).
• Surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
• Stable psychosocial support system with caregiver(s) capable of monitoring the participant throughout the study. Caregivers must be willing and able to be present and provide routine care during all study activities except during hospitalization for device implantation.
• Ability to understand and comply with study session instructions determined through the regular administration of simple study questionnaires.
• Strong and frequent muscle spasms not controlled by medication

Sponsors & Collaborators

• Johns Hopkins University: lead
• UMC Utrecht: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Locked-In Syndrome

Condition Hierarchy (Ancestors)

Quadriplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan Crone, MD

  Professor of Neurology, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 6, 2020
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

US (1)