COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2026-09-30

Brief Summary

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The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

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Detailed Description

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Conditions

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Neurologic Disorder Paralysis Paralysis; Stroke Amyotrophic Lateral Sclerosis Muscular Dystrophies Spinal Cord Injuries Stroke, Lacunar Stroke Brainstem Cervical Spinal Cord Injury Spinal Muscular Atrophy Tetraplegic; Paralysis Quadriplegia/Tetraplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Single

Implantation of the motor neuroprosthesis medical device.

Group Type OTHER

Motor Neuroprosthesis (MNP)

Intervention Type DEVICE

Type of implantable brain computer interface

Interventions

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Motor Neuroprosthesis (MNP)

Type of implantable brain computer interface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Severe quadriparesis
2. Able to give consent
3. Appropriate candidate for neurointerventional procedure
4. Able and willing to access all clinical testing and not impeded by geographical location
5. Proficient in English
6. Have a study partner

Exclusion Criteria

1. Active condition resulting in immunosuppression
2. Unsuitable for general anesthesia
3. Anaphylactic allergy to contrast media
4. Allergy to nickel
5. History of pulmonary embolism
6. History of recent deep vein thrombosis
7. Psychiatric or psychological disorder
8. No study partner or caregiver
9. Unable to provide evidence of COVID vaccination

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No