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Completed

NCT Number: NCT02564419

Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Activa PC+S

Device

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 outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

Jonathan Jagid

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: BMI

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2015
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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