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

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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Medtronic Activa PC+S

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine/Miami Project to Cure Paralysis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jonathan Jagid
• Collaborators: Medtronic
• Investigators: Principal Investigator: Jonathan R Jagid, MD, University of Miami

Publications and helpful links

General Publications

• Davis KC, Meschede-Krasa B, Cajigas I, Prins NW, Alver C, Gallo S, Bhatia S, Abel JH, Naeem JA, Fisher L, Raza F, Rifai WR, Morrison M, Ivan ME, Brown EN, Jagid JR, Prasad A. Design-development of an at-home modular brain-computer interface (BCI) platform in a case study of cervical spinal cord injury. J Neuroeng Rehabil. 2022 Jun 3;19(1):53. doi: 10.1186/s12984-022-01026-2.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 20150244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes