Trial Outcomes & Findings for ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis (NCT NCT01393444)

Results Overview

Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Up to 29 days of device implantation

Results posted on

2016-12-12

Participant Flow

Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations

This study did not include "arms" or group assignments.

Participant milestones

Participant milestones
Measure	Direct Brain Interface Users All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Overall Study STARTED	6
Overall Study First (1st Implanted) Subject Enrolled	1
Overall Study Second Subject Enrolled	1
Overall Study Third Subject Enrolled	1
Overall Study Fourth Subject Enrolled	1
Overall Study Fifth (2nd Implanted) Subject Enrolled	1
Overall Study Sixth (3rd Implanted) Subject	1
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Direct Brain Interface Users All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Overall Study Withdrawal by Subject	1
Overall Study Determined ineligible during screening.	2

Baseline Characteristics

ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Brain Interface Users n=6 Participants All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 29 days of device implantation

Population: Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.

Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.

Outcome measures

Outcome measures
Measure	Direct Brain Interface Users n=3 Participants All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG	3 participants

SECONDARY outcome

Timeframe: Up to 29 days of device implantation

Population: Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.

Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.

Outcome measures

Outcome measures
Measure	Direct Brain Interface Users n=3 Participants All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System	3 participants

Adverse Events

Direct Brain 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	Direct Brain Interface Users n=6 participants at risk All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms. Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants
Musculoskeletal and connective tissue disorders Neck pain following implant surgery	16.7% 1/6 • Number of events 1 • 6 months The period of enrollment for participants who completed the study approximately 6 months. This included up to 3 months of screening visits, 1 month of testing during implantation, and up to 2 months of follow-up.

Additional Information

Jennifer Collinger

University of Pittsburgh

Phone: 412-383-1274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place