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Brain Machine Interface (BMI) in Subjects Living With Quadriplegia (BMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02564419
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Jagid, University of Miami

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Medtronic Activa PC+S Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medtronic Activa PC+S

Objective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by;

  1. Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level).
  2. Assessing the feasibility of activating fundamental upper extremity muscles to reproduce hand grasp.

These are important first steps towards creating and designing a device that can enhance or assist in performing activities of daily living (ADL) in the life of these subjects. Attachment 15.3

Device: Medtronic Activa PC+S
Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.




Primary Outcome Measures :
  1. Composite Outcome Measures Including: Neurological exams, questionnaires, functional hand testing, Adverse events [ Time Frame: 24 months ]
    Participants will undergo the following assessments: AIS motor and sensory score; SF-36 and Health Assessment Questionnaire (HAQ); muscle force test; range of motion; SCIM III; JTT hand function test; pinch grip strength.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564419


Locations
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United States, Florida
University of Miami School of Medicine/Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jonathan Jagid
Investigators
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Principal Investigator: Jonathan R Jagid, MD University of Miami
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Responsible Party: Jonathan Jagid, Associate Professor of Neurological Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT02564419    
Other Study ID Numbers: 20150244
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System