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

Synchron Medical, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Neurologic Disorder Paralysis Paralysis; Stroke Amyotrophic Lateral Sclerosis Muscular Dystrophies Spinal Cord Injury

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Severe motor impairment 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 anaesthetic 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

Locations (3)

Sydney Local Health District

Sydney, New South Wales, Australia

Metro North Health

Brisbane, Queensland, Australia

Melbourne Health

Melbourne, Victoria, Australia

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes