Trial Outcomes & Findings for Microelectrode Brain-Machine Interface for Individuals With Tetraplegia (NCT NCT01364480)

Last Updated: 2024-01-09

Results Overview

Number of participants who were implanted for at least one year without having to explant the device for safety reasons.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

One year following array implantation

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Brain-Machine Interface Users All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brain-Machine Interface Users n=1 Participants All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year following array implantation

Number of participants who were implanted for at least one year without having to explant the device for safety reasons.

Outcome measures

Outcome measures
Measure	Brain-Machine Interface Users n=1 Participants All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Number of Participants With Successful Implant	1 Participants

SECONDARY outcome

Timeframe: One year following array implantation

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.

Outcome measures

Outcome measures
Measure	Brain-Machine Interface Users n=1 Participants All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
7 Degree-of-freedom Movement by Neural Control	16 score on a scale

SECONDARY outcome

Timeframe: One year following array implantation

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.

Outcome measures

Outcome measures
Measure	Brain-Machine Interface Users n=1 Participants All participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Implantation of NeuroPort Arrays in the motor cortex: Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
10 Degree-of-freedom Movement by Neural Control	15.6 score on a scale

Adverse Events

Brain-Machine Interface Users

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brain-Machine Interface Users n=1 participants at risk All eligible participants enrolled in the study will undergo Implantation of NeuroPort Arrays in the motor cortex. There is no control group. Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
Skin and subcutaneous tissue disorders Skin retraction at pedestal site	100.0% 1/1 • Number of events 1 • through study completion, 2 years, 8.5 months duration of implant

Additional Information

Debbie Harrington, CCRP, senior research coordinator

University of Pittsburgh

Phone: 4123831355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place