SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05041114 |
Recruitment Status :
Withdrawn
(Study moved to U.S.)
First Posted : September 10, 2021
Last Update Posted : March 21, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment. |
Actual Study Start Date : | April 21, 2022 |
Actual Primary Completion Date : | November 30, 2022 |
Actual Study Completion Date : | November 30, 2022 |
Arm | Intervention/treatment |
---|---|
Single
Implantation of motor neuroprosthesis medical device.
|
Device: Motor Neuroprosthesis
Type of implantable brain computer interface |
- Treatment related adverse events [ Time Frame: 12 months post implant ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041114
Australia, New South Wales | |
Sydney Local Health District | |
Sydney, New South Wales, Australia | |
Australia, Queensland | |
Metro North Health | |
Brisbane, Queensland, Australia | |
Australia, Victoria | |
Melbourne Health | |
Melbourne, Victoria, Australia, 3050 |
Responsible Party: | Synchron Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT05041114 |
Other Study ID Numbers: |
S-01-02 |
First Posted: | September 10, 2021 Key Record Dates |
Last Update Posted: | March 21, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Muscular Dystrophies Stroke Spinal Cord Injuries Motor Neuron Disease Amyotrophic Lateral Sclerosis Muscular Atrophy Muscular Atrophy, Spinal Paralysis Nervous System Diseases Stroke, Lacunar Brain Stem Infarctions Wounds and Injuries Arm Injuries Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Spinal Cord Diseases Trauma, Nervous System Atrophy Pathological Conditions, Anatomical Neurodegenerative Diseases Neuromuscular Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Muscular Disorders, Atrophic Muscular Diseases |