Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Study Overview
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Brief Summary
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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 either processed in the Activa PC+S; or off-loaded via the Nexus D communication device (Medtronic) to a computer.

Official Title
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Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Medtronic Activa PC+S


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medtronic Activa PC+S<br>Objective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by; Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level). 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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIS Motor Score | 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 | Up to 2 years | 
| AIS Sensory Score | 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. | Up to 2 years | 
| SF-36 scores | Short Form 36 (SF-36) is a 36 item self-report health questionnaire | Up to 2 years | 
| Muscle Force Test | 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 | Up to 2 years | 
| Range of Motion | Joint Range of Motion for both active and passive for Flexion and extension | Up to 2 years | 
| SCIM III (Spinal Cord Independence Measure) | Self-report independence for daily activities of living scored from 1-6 | Up to 2 years | 
| JTT Hand Function Test | Functional timed activities such as hand writing, page turning, lifting small objects, feeding, stacking checkers, lifting light cans and lifting heavy cans | Up to 2 years | 
| Pinch Grip Strength | Measurement of grip strength throughout training | Up to 2 years | 
| Modified Ashworth Scale | Muscle tone scored during stretch from 0 to 5 | Up to 2 years |