Brain Machine Interface (BMI) in Subjects Living With Quadriplegia
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 22 - 50 |
| Updated: | 11/9/2018 |
| Start Date: | November 2015 |
| End Date: | June 1, 2019 |
| Contact: | Letitia Fisher |
| Email: | lfisher@med.miami.ed |
| Phone: | 305-243-7108 |
Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
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.
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.
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.
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.
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
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Jonathan R Jagid, MD
Phone: 305-243-7108
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