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

Not Applicable

Withdrawn

• Conditions: Paralysis; Spinal Muscular Atrophy; Paralysis; Stroke; Spinal Cord Injury; Muscular Dystrophies; Stroke, Lacunar; Amyotrophic Lateral Sclerosis; Stroke, Brainstem; Neurologic Disorder; Upper Limb Injury
• Interventions: Device: Motor Neuroprosthesis

• Registration Number: NCT05041114
• Lead Sponsor: Synchron Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-10
• Study Start: 2022-04-21
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	Motor Neuroprosthesis	Implantation of motor neuroprosthesis medical device.

Primary Outcome Measures

Name	Time	Method
Treatment related adverse events	12 months post implant

Trial Locations

Locations (3)

Metro North Health; 🇦🇺 Brisbane, Queensland, Australia

Melbourne Health; 🇦🇺 Melbourne, Victoria, Australia

Sydney Local Health District; 🇦🇺 Sydney, New South Wales, Australia