Neurologic DisorderNCT05035823
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
A study testing Motor Neuroprosthesis (MNP) in people with Neurologic Disorder and Paralysis, run by Synchron Medical, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Neurologic Disorder, Paralysis, Paralysis; Stroke
- What is being tested?
- Motor Neuroprosthesis (MNP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2022to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Psychiatric or psychological disorder
- No study partner or caregiver
- Unable to provide evidence of COVID vaccination
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University at Buffalo Neurosurgery (UBNS)
Buffalo, New York, 14203
Mount Sinai Health System
New York, New York, 10029
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injuries
- Being tested
- Motor Neuroprosthesis (MNP)
- Medical subject headings
- Nervous System Diseases, Paralysis, Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injuries, Stroke, Lacunar, Brain Stem Infarctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Neuroprosthesis (MNP)Device
Type of implantable brain computer interface
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Implantation of the motor neuroprosthesis medical device. Receives: Device: Motor Neuroprosthesis (MNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Serious Adverse Events
Number of subjects with treatment-related adverse events
Measured: 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start27 Apr 2022
- Primary completion19 Sep 2024
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synchron Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035823
- Sponsor's protocol ID
- S-02-01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chetty N, Bennett J, Schone HR, Fry A, Yoo PE, Lacomis D, Oxley TJ, Collinger JL, Putrino DF, Weber DJ. Measuring motor intent for BCI control-A comparative analysis of signal quality of simultaneously recorded vECoG and scalp EEG. J Neural Eng. 2026 Sep 17;23(5):056022. doi: 10.1088/1741-2552/ae9eef.
PubMed 42750660Chetty N, Kacker K, Feldman AK, Yoo PE, Bennett J, Fry A, Tal I, Hardy NF, Ebrahimi S, Echavarria C, Sawyer A, Schone HR, Harel NY, Nogueira RG, Majidi S, Levy EI, Kandel A, Hill KK, Opie NL, Lacomis D, Collinger JL, Oxley TJ, Putrino DF, Weber DJ. Signal properties and stability of a chronically implanted endovascular brain computer interface. medRxiv [Preprint]. 2025 Sep 25:2025.09.19.25335897. doi: 10.1101/2025.09.19.25335897.
PubMed 41040697
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05035823
- Acronym / sponsor ID
- S-02-01
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Synchron Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Device: Motor Neuroprosthesis (MNP)Implantation of the motor neuroprosthesis medical device. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Active condition resulting in immunosuppression
- Unsuitable for general anesthesia
- Anaphylactic allergy to contrast media
- Allergy to nickel
- History of pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Neuroprosthesis (MNP)Type of implantable brain computer interface | Device | Single |
Primary outcome
Treatment-Related Serious Adverse Events
Time frame: 12 months post implant
Number of subjects with treatment-related adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 42750660Chetty N, Bennett J, Schone HR, Fry A, Yoo PE, Lacomis D, Oxley TJ, Collinger JL, Putrino DF, Weber DJ. Measuring motor intent for BCI control-A comparative analysis of signal quality of simultaneously recorded vECoG and scalp EEG. J Neural Eng. 2026 Sep 17;23(5):056022. doi: 10.1088/1741-2552/ae9eef.
- Derived from this study: PubMed 41040697Chetty N, Kacker K, Feldman AK, Yoo PE, Bennett J, Fry A, Tal I, Hardy NF, Ebrahimi S, Echavarria C, Sawyer A, Schone HR, Harel NY, Nogueira RG, Majidi S, Levy EI, Kandel A, Hill KK, Opie NL, Lacomis D, Collinger JL, Oxley TJ, Putrino DF, Weber DJ. Signal properties and stability of a chronically implanted endovascular brain computer interface. medRxiv [Preprint]. 2025 Sep 25:2025.09.19.25335897. doi: 10.1101/2025.09.19.25335897.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Neuroprosthesis (MNP) in people with Neurologic Disorder and Paralysis, run by Synchron Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Serious Adverse Events (time frame: 12 months post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.