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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05041114
• Other study ID #: S-01-02
• Status: Withdrawn
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Synchron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Arm Injuries
• Brain Stem Infarctions
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Nervous System Diseases
• Neurologic Disorder
• Paralysis
• Spinal Cord Injuries
• Spinal Cord Injury
• Spinal Muscular Atrophy
• Stroke
• Stroke, Lacunar
• Upper Limb Injury
• Wounds and Injuries

Intervention

Device:
• Motor Neuroprosthesis
Type of implantable brain computer interface

Locations

Country	Name	City	State
Australia	Metro North Health	Brisbane	Queensland
Australia	Melbourne Health	Melbourne	Victoria
Australia	Sydney Local Health District	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Synchron Medical, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related adverse events		12 months post implant