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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

Tracking Information
First Submitted Date  ICMJE August 18, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date September 18, 2020
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • 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
  • 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.
  • SF-36 scores [ Time Frame: Up to 2 years ]
    Short Form 36 (SF-36) is a 36 item self-report health questionnaire
  • 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
  • Range of Motion [ Time Frame: Up to 2 years ]
    Joint Range of Motion for both active and passive for Flexion and extension
  • SCIM III (Spinal Cord Independence Measure) [ Time Frame: Up to 2 years ]
    Self-report independence for daily activities of living scored from 1-6
  • 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
  • Pinch Grip Strength [ Time Frame: Up to 2 years ]
    Measurement of grip strength throughout training
  • Modified Ashworth Scale [ Time Frame: Up to 2 years ]
    Muscle tone scored during stretch from 0 to 5
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Machine Interface (BMI) in Subjects Living With Quadriplegia
Official Title  ICMJE Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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.
Study Arms  ICMJE 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

Intervention: Device: Medtronic Activa PC+S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
3
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02564419
Other Study ID Numbers  ICMJE 20150244
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Jagid, University of Miami
Study Sponsor  ICMJE Jonathan Jagid
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Jonathan R Jagid, MD University of Miami
PRS Account University of Miami
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP