ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
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| ClinicalTrials.gov Identifier: NCT01393444 |
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Recruitment Status :
Completed
First Posted : July 13, 2011
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
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Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Tetraplegia Spinal Cord Injury Brachial Plexus Injury Muscular Dystrophy ALS Brainstem Stroke | Device: Implantation of ECoG sensors on the brain surface | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Official Title: | Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Implantation of ECoG sensors on the brain surface
One ECoG sensor will be implanted over the motor cortex of study participants
Other Names:
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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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jennifer Collinger, PhD, Assistant Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01393444 History of Changes |
| Other Study ID Numbers: |
PRO10010149 |
| First Posted: | July 13, 2011 Key Record Dates |
| Results First Posted: | December 12, 2016 |
| Last Update Posted: | December 12, 2016 |
| Last Verified: | October 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Electrocorticography Tetraplegia Spinal cord injury Brainstem stroke Neuroprosthetic |
Brain-computer interface Direct brain interface Neural activity Motor cortex |
Additional relevant MeSH terms:
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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 |