ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis - Full Text View

Purpose

The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.

Condition	Intervention
Tetraplegia Spinal Cord Injury Brachial Plexus Injury Muscular Dystrophy ALS Brainstem Stroke	Device: Implantation of ECoG sensors on the brain surface


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis

Resource links provided by NLM:

MedlinePlus related topics: Paralysis Spinal Cord Injuries

Genetic and Rare Diseases Information Center resources: Muscular Dystrophy

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

The primary outcome is the successful control of a variety of external devices using neural data recorded with ECoG. [ Time Frame: Up to 29 days of device implantation ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

A secondary outcome is to demonstrate that individuals with upper limb paralysis can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain-computer interface system. [ Time Frame: Up to 29 days of device implantation ] [ Designated as safety issue: No ]
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.


Enrollment:	3
Study Start Date:	May 2011
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Device: Implantation of ECoG sensors on the brain surface One ECoG sensor will be implanted over the motor cortex of study participants Other Names: brain-computer interface neuroprosthetic

Detailed Description:

Brain-computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices, offering a natural and rich control signal for prosthetic hands or functional electrical stimulators (FES) to re-animate paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity using electrodes implanted on the surface of the brain. Each participant will undergo testing of the ECoG direct brain interface for up to 29 days. Participants will learn to control computer cursors, virtual reality environments, and assistive devices such as hand orthoses and functional electrical stimulators using neural activity recorded with the ECoG sensor.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Limited or no ability to use both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases
At least 1 year post-injury
Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days)
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
Additional exclusion criteria must also be reviewed

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393444

Locations


United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators


Principal Investigator:	Jennifer L Collinger, PhD	University of Pittsburgh

More Information

Additional Information:

Brain Computer Interface Research at University of Pittsburgh Medical Center (UPMC) / University of Pittsburgh This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site


Responsible Party:	Jennifer Collinger, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01393444 History of Changes
Other Study ID Numbers:	PRO10010149
Study First Received:	July 11, 2011
Last Updated:	July 19, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	Yes
Plan Description:	Study sponsors, as well as the FDA, will have access to research data and documents in order to monitor the integrity of the study.

Keywords provided by University of Pittsburgh:


Electrocorticography Tetraplegia Spinal cord injury Brainstem stroke Neuroprosthetic	Brain-computer interface Direct brain interface Neural activity Motor cortex

Additional relevant MeSH terms:


Wounds and Injuries Spinal Cord Injuries Muscular Dystrophies Paralysis Quadriplegia Brain Stem Infarctions Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Muscular Disorders, Atrophic Muscular Diseases	Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Neurologic Manifestations Signs and Symptoms Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Stroke Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016