ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
This study is currently recruiting participants.
Verified July 2011 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01393444
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
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Purpose
The purpose of this research study is to demonstrate that individuals with upper limb paralysis, such as tetraplegia due to spinal cord injury, can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.
| Condition | Intervention |
|---|---|
|
Tetraplegia Spinal Cord Injury |
Device: Implantation of ECoG sensors on the brain surface |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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:
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.
| Estimated Enrollment: | 3 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Direct Brain Interface Users
All participants enrolled in the study will be individuals implanted with an ECoG sensor on the surface of their brain to record neural activity. There is no control group.
|
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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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 55 Years |
| 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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393444
Contacts
| Contact: Elizabeth A Harchick | 412-383-1355 | eat18@pitt.edu |
Locations
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Elizabeth A Harchick 412-383-1355 eat18@pitt.edu | |
| Principal Investigator: Wei Wang, MD, PhD | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Wei Wang, MD, PhD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Wei Wang, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01393444 History of Changes |
| Other Study ID Numbers: | PRO10010149 |
| Study First Received: | July 11, 2011 |
| Last Updated: | July 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Quadriplegia Spinal Cord Injuries Paralysis Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013