Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Jonathan Jagid

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: Medtronic Activa PC+S

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02564419

20150244

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 22 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Medtronic Activa PC+S

Experimental group

Description:

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

Treatment:

Device: Medtronic Activa PC+S