Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

Spinal Cord Injury Clinical Trial

— BMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564419
• Other study ID #: 20150244
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 30, 2019

Study information

• Verified date: September 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami School of Medicine/Miami Project to Cure Paralysis	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jonathan Jagid	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	SF-36 scores	Short Form 36 (SF-36) is a 36 item self-report health questionnaire	Up to 2 years
Primary	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
Primary	Range of Motion	Joint Range of Motion for both active and passive for Flexion and extension	Up to 2 years
Primary	SCIM III (Spinal Cord Independence Measure)	Self-report independence for daily activities of living scored from 1-6	Up to 2 years
Primary	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
Primary	Pinch Grip Strength	Measurement of grip strength throughout training	Up to 2 years
Primary	Modified Ashworth Scale	Muscle tone scored during stretch from 0 to 5	Up to 2 years