Back to resultsCOMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Primary Purpose
Neurologic Disorder, Paralysis, Paralysis; Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor Neuroprosthesis (MNP)
Sponsored by
About this trial
This is an interventional device feasibility trial for Neurologic Disorder
Eligibility Criteria
Inclusion Criteria:
- Severe quadriparesis
- 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 anesthesia
- 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
Sites / Locations
- University at Buffalo Neurosurgery (UBNS)Recruiting
- Mount Sinai Health SystemRecruiting
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single
Arm Description
Implantation of the motor neuroprosthesis medical device.
Outcomes
Primary Outcome Measures
Treatment-Related Serious Adverse Events
Number of subjects with treatment-related adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT05035823
First Posted
September 1, 2021
Last Updated
April 13, 2023
Sponsor
Synchron Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05035823
Brief Title
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Official Title
Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synchron Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injuries, Stroke, Lacunar, Stroke Brainstem, Cervical Spinal Cord Injury, Spinal Muscular Atrophy, Tetraplegic; Paralysis, Quadriplegia/Tetraplegia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Other
Arm Description
Implantation of the motor neuroprosthesis medical device.
Intervention Type
Device
Intervention Name(s)
Motor Neuroprosthesis (MNP)
Intervention Description
Type of implantable brain computer interface
Primary Outcome Measure Information:
Title
Treatment-Related Serious Adverse Events
Description
Number of subjects with treatment-related adverse events
Time Frame
12 months post implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe quadriparesis
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 anesthesia
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
Facility Information:
Facility Name
University at Buffalo Neurosurgery (UBNS)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen Gay
Phone
716-440-4231
Email
jgay@ubns.com
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Lapinska
Phone
646-689-1776
Email
marta.lapinska@mountsinai.org
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Onesi
Phone
412-385-7711
Email
onesisa2@upmc.edu
12. IPD Sharing Statement
Learn more about this trial
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
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