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

NCT05041114 | Withdrawn DMC

• 1 other identifier: S-01-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neurologic Disorder; Paralysis; Paralysis; Stroke; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Spinal Cord Injury; Stroke, Lacunar; Stroke, Brainstem; Upper Limb Injury; Spinal Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• Treatment related adverse events

  12 months post implant

Study Arms (1)

Single

OTHER

Implantation of motor neuroprosthesis medical device.

Device: Motor Neuroprosthesis

Interventions

Motor Neuroprosthesis DEVICE

Type of implantable brain computer interface

Single

Eligibility Criteria

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

You may qualify if:

• Severe motor impairment
• Able to give consent
• Appropriate candidate for neurointerventional procedure
• Able and willing to access all clinical testing and not impeded by geographical location
• Proficient in English
• Have a study partner

You may not qualify if:

• Active condition resulting in immunosuppression
• Unsuitable for general anaesthetic
• Anaphylactic allergy to contrast media
• Allergy to nickel
• History of pulmonary embolism
• History of recent deep vein thrombosis
• Psychiatric or psychological disorder
• No study partner or caregiver
• Unable to provide evidence of COVID vaccination

Sponsors & Collaborators

• Synchron Medical, Inc.: lead

Study Sites (3)

Sydney Local Health District

Sydney, New South Wales, Australia

Location

Metro North Health

Brisbane, Queensland, Australia

Location

Melbourne Health

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Nervous System Diseases; Paralysis; Stroke; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Spinal Cord Injuries; Stroke, Lacunar; Brain Stem Infarctions; Arm Injuries; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Trauma, Nervous System; Wounds and Injuries; Cerebral Small Vessel Diseases; Thrombotic Stroke; Ischemic Stroke; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Brain Ischemia

Study Design

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

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 10, 2021
• Study Start: April 21, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

AU (3)