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

Synchron Medical

Status: Withdrawn

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

Treatments: Device: Motor Neuroprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05041114

S-01-02

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single

Other group

Description:

Implantation of motor neuroprosthesis medical device.

Treatment:

Device: Motor Neuroprosthesis