- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041114
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New South Wales
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Sydney, New South Wales, Australia
- Sydney Local Health District
-
-
Queensland
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Brisbane, Queensland, Australia
- Metro North Health
-
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Victoria
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Melbourne, Victoria, Australia, 3050
- Melbourne Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single
Implantation of motor neuroprosthesis medical device.
|
Type of implantable brain computer interface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment related adverse events
Time Frame: 12 months post implant
|
12 months post implant
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Trauma, Nervous System
- Brain Ischemia
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Muscular Disorders, Atrophic
- Atrophy
- Infarction
- Brain Infarction
- Cerebral Small Vessel Diseases
- Thrombotic Stroke
- Ischemic Stroke
- Stroke
- Wounds and Injuries
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Muscular Dystrophies
- Nervous System Diseases
- Muscular Atrophy
- Paralysis
- Spinal Cord Injuries
- Muscular Atrophy, Spinal
- Arm Injuries
- Stroke, Lacunar
- Brain Stem Infarctions
Other Study ID Numbers
- S-01-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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