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Miami, Florida 33136


Purpose:

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be 1. either processed in the Activa PC+S; or 2. off-loaded via the Nexus D communication device (Medtronic) to a computer.


Study summary:

Medical device manufacturer Medtronic has developed a fully-implantable, bi-directional neuroprosthetic that is built upon existing deep brain stimulation (DBS) technology and has the ability to perform electrocorticogram recording and deliver functional electrical stimulation. This device is an incremental improvement to an existing Premarket Approved (PMA) deep brain stimulation (DBS) device the Activa PC. The incremental improvement enables sensing and algorithmic capabilities while maintaining full functionality for therapy delivery without appreciable loss of device longevity [9]. Our investigator initiated feasibility trial seeks to test the Activa PC+S as a therapeutic system to restore movement to paralyzed muscles. Our mission is to develop and demonstrate in humans innovative direct neural interface technology that restores motor function, rehabilitates, and improves the quality of life of individuals with SCI. Investigators seek to enable testing that will lead to innovative neuroprosthetic therapies that improve recovery by retraining the nervous system, reduce secondary conditions, and create a better life for persons with SCI and other conditions that impair physical or cognitive function. This project will increase the understanding and tempo of research into the modes of functionality of a fully implantable system from the following perspectives: neurosurgery, biomedical engineering, rehabilitation, and therapeutics. A major strength of our approach is that it incrementally tests sub-components of the system through a systematic buildup of functionality towards control of upper extremity function.


Criteria:

Inclusion Criteria: - AIS Grades A & B - Level of Injury C5 or C6 - Local Community dwelling - Stable chronic injury - Stable health status and upper extremities - Completion of Clinical Protocol 01 Exclusion Criteria: - Coagulopathy - Anticoagulation - Pregnancy


NCT ID:

NCT02564419


Primary Contact:

Principal Investigator
Jonathan R Jagid, MD
University of Miami


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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