Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Spinal Cord Injury Clinical Trial

Official title:

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01364480
• Other study ID #: STUDY19030235
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2011
• Est. completion date: November 26, 2022

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Description:

Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
• At least 1 year post-injury
• Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
• Additional inclusion criteria must also be reviewed

Exclusion Criteria:

• Certain implanted devices
• Presence of other serious disease or disorder that could affect ability to participate in this study
• Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
• Additional exclusion criteria must also be reviewed

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia

Intervention

Device:
• Implantation of NeuroPort Arrays in the motor cortex
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Michael Boninger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Successful Implant	Number of participants who were implanted for at least one year without having to explant the device for safety reasons.	One year following array implantation
Secondary	7 Degree-of-freedom Movement by Neural Control	A modified Action Research Arm Test (ARAT) assessment for upper extremity performance was conducted to evaluate neural control of movement of a robotic prosthetic arm with 7 independent degrees of freedom controlled simultaneously. The degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 1D open/closing of hand. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Each test item was timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.	One year following array implantation
Secondary	10 Degree-of-freedom Movement by Neural Control	A modified ARAT was conducted to assess neural control of movement of a robotic prosthetic arm with 10 independent degrees of freedom, controlled simultaneously. Degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 4 degrees dictating hand shape, including pinch (flexion of thumb, index and middle fingers), scoop (flexion of ring and pinky fingers), finger abduction (of index, ring and little fingers), and thumb opposition. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Test items were timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s to complete were scored as 2. The participant attempted each assessment three times and the best score was included. The total possible score ranged from 0 to 27 (i.e., max possible score of 3 each for 9 total tasks). A higher score indicates a better outcome.	One year following array implantation