Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Jonathan Jagid1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Medtronic Activa PC+SDEVICE

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami School of Medicine/Miami Project to Cure Paralysis

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Up to 2 years

SF-36 scores

Short Form 36 (SF-36) is a 36 item self-report health questionnaire

Time frame: 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

Time frame: Up to 2 years

Range of Motion

Joint Range of Motion for both active and passive for Flexion and extension

Time frame: Up to 2 years

SCIM III (Spinal Cord Independence Measure)

Self-report independence for daily activities of living scored from 1-6

Time frame: 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

Time frame: Up to 2 years

Pinch Grip Strength

Data from ClinicalTrials.gov

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