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COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

S

Synchron Medical

Status

Active, not recruiting

Conditions

Stroke Brainstem
Spinal Cord Injuries
Paralysis; Stroke
Cervical Spinal Cord Injury
Neurologic Disorder
Quadriplegia/Tetraplegia
Spinal Muscular Atrophy
Tetraplegic; Paralysis
Paralysis
Stroke, Lacunar
Amyotrophic Lateral Sclerosis
Muscular Dystrophies

Treatments

Device: Motor Neuroprosthesis (MNP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05035823
S-02-01

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Severe quadriparesis
  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 anesthesia
  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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Single
Other group
Description:
Implantation of the motor neuroprosthesis medical device.
Treatment:
Device: Motor Neuroprosthesis (MNP)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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