NCT05035823

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2022Sep 2026

First Submitted

Initial submission to the registry

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

September 1, 2021

Last Update Submit

April 24, 2025

Conditions

Neurologic DisorderParalysisParalysis; StrokeAmyotrophic Lateral SclerosisMuscular DystrophiesSpinal Cord InjuriesStroke, LacunarStroke BrainstemCervical Spinal Cord InjurySpinal Muscular AtrophyTetraplegic; ParalysisQuadriplegia/Tetraplegia

Outcome Measures

Primary Outcomes (1)

  • Treatment-Related Serious Adverse Events

    Number of subjects with treatment-related adverse events

    12 months post implant

Study Arms (1)

Single

OTHER

Implantation of the motor neuroprosthesis medical device.

Device: Motor Neuroprosthesis (MNP)

Interventions

Motor Neuroprosthesis (MNP)DEVICE

Type of implantable brain computer interface

Single

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University at Buffalo Neurosurgery (UBNS)

Buffalo, New York, 14203, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Chetty 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.

    PMID: 41040697DERIVED

MeSH Terms

Conditions

Nervous System DiseasesParalysisStrokeAmyotrophic Lateral SclerosisMuscular DystrophiesSpinal Cord InjuriesStroke, LacunarBrain Stem InfarctionsMuscular Atrophy, SpinalQuadriplegia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTrauma, Nervous SystemWounds and InjuriesCerebral Small Vessel DiseasesThrombotic StrokeIschemic StrokeBrain InfarctionInfarctionIschemiaPathologic ProcessesNecrosisBrain Ischemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 5, 2021

Study Start

April 27, 2022

Primary Completion

September 19, 2024

Study Completion (Estimated)

September 1, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

US(3)