Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: Medtronic Activa PC+S

• Registration Number: NCT02564419
• Lead Sponsor: Jonathan Jagid

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 available

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2015-11
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medtronic Activa PC+S	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

Primary Outcome Measures

Name	Time	Method
AIS Motor Score	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
SF-36 scores	Up to 2 years	Short Form 36 (SF-36) is a 36 item self-report health questionnaire
Modified Ashworth Scale	Up to 2 years	Muscle tone scored during stretch from 0 to 5
Range of Motion	Up to 2 years	Joint Range of Motion for both active and passive for Flexion and extension
SCIM III (Spinal Cord Independence Measure)	Up to 2 years	Self-report independence for daily activities of living scored from 1-6
AIS Sensory Score	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.
Muscle Force Test	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
JTT Hand Function Test	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	Up to 2 years	Measurement of grip strength throughout training

Trial Locations

Locations (1)

University of Miami School of Medicine/Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States