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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 : Active, not recruiting
First Posted : September 10, 2021
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Synchron, Inc. ( Synchron Medical, Inc. )

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.
Actual Study Start Date : April 24, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024


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




Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: 12 months post implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Synchron Medical, Inc.
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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: December 9, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Stroke
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Atrophy
Paralysis
Muscular Atrophy, Spinal
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