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ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
This study has been completed.
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01393444
First received: July 11, 2011
Last updated: October 18, 2016
Last verified: October 2016
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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: | 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:
Further study details as provided by Jennifer Collinger, PhD, University of Pittsburgh:
Primary Outcome Measures:
- Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG [ Time Frame: Up to 29 days of device implantation ]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:
- Number of Participants Able to 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 ]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: | 6 |
| 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:
|
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) |
| Sexes Eligible for Study: | All |
| 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
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:
| 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 |
| Results First Received: | August 17, 2016 |
| Last Updated: | October 18, 2016 |
| 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 Jennifer Collinger, PhD, 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 June 23, 2017