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

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ClinicalTrials.gov Identifier: NCT02564419
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Medtronic
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.
Masking: None (Open Label)
Masking Description: Participants will be undergoing a unilateral implantation of the Medtronic Active PC+S with unilateral subdural strip electrodes over the motor cortex. They will receive 24 sessions over a 3-6 month period which consists of external stimulation.
Primary Purpose: Device Feasibility
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
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

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. AIS Motor Score [ Time Frame: Up to 2 years ]
    American Spinal Injury Association (ASIA) Impairment Scale (AIS) Motor scores has a score totaling 0-50 for the upper limbs and 0-50 for the lower limbs with the lower score indicating greater motor impairment

  2. AIS Sensory Score [ Time Frame: Up to 2 years ]
    AIS Sensory scores has a score totaling 0-56 points for light touch and pin prick modalities for a total of a maximum of 112 points per side of the body. The lower scores indicate greater sensory impairment.

  3. SF-36 scores [ Time Frame: Up to 2 years ]
    Short Form 36 (SF-36) is a 36 item self-report health questionnaire

  4. Muscle Force Test [ Time Frame: Up to 2 years ]
    0. No movement;1.Palpable contraction, no visible movement; 2. Movement but only with gravity eliminated; 3. Movement against gravity; 4. Movement against resistance but weaker than normal; 5. Normal power

  5. Range of Motion [ Time Frame: Up to 2 years ]
    Joint Range of Motion for both active and passive for Flexion and extension

  6. SCIM III (Spinal Cord Independence Measure) [ Time Frame: Up to 2 years ]
    Self-report independence for daily activities of living scored from 1-6

  7. JTT Hand Function Test [ Time Frame: Up to 2 years ]
    Functional timed activities such as hand writing, page turning, lifting small objects, feeding, stacking checkers, lifting light cans and lifting heavy cans

  8. Pinch Grip Strength [ Time Frame: Up to 2 years ]
    Measurement of grip strength throughout training

  9. Modified Ashworth Scale [ Time Frame: Up to 2 years ]
    Muscle tone scored during stretch from 0 to 5



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
Medtronic
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: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries