STENTRODE™ WITH THOUGHT CONTROLLED DIGITAL SWITCH: An Early Feasibility Study (EFS) of the Safety of an Endovascular Motor Neuroprosthesis (MNP) Device in Participants With Severe Upper Limb Impairment.

Sponsor

Synchron Medical, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05041114

Collaborator

(none)

Enrollment

Locations

Arm

25.3

Anticipated Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurologic Disorder Paralysis Paralysis; Stroke Amyotrophic Lateral Sclerosis Muscular Dystrophies Spinal Cord Injury Stroke, Lacunar Stroke, Brainstem Upper Limb Injury Spinal Muscular Atrophy	Device: Motor Neuroprosthesis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

STENTRODE™ WITH THOUGHT CONTROLLED DIGITAL SWITCH: An Early Feasibility Study (EFS) of the Safety of an Endovascular Motor Neuroprosthesis (MNP) Device in Participants With Severe Upper Limb Impairment.

Actual Study Start Date :

Apr 24, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Implantation of motor neuroprosthesis medical device.	Device: Motor Neuroprosthesis Type of implantable brain computer interface

Arm

Intervention/Treatment

Other: Single

Implantation of motor neuroprosthesis medical device.

Device: Motor Neuroprosthesis

Type of implantable brain computer interface

Outcome Measures

Primary Outcome Measures

Treatment related adverse events [12 months post implant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sydney Local Health District	Sydney	New South Wales	Australia
2	Metro North Health	Brisbane	Queensland	Australia
3	Melbourne Health	Melbourne	Victoria	Australia	3050