An interventional study of Implantation of ECoG sensors on the brain surface in Tetraplegia, Spinal Cord Injury and Brachial Plexus Injury, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by University of Pittsburgh · Not applicable and Interventional
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.
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.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's enrollment of 6 is below the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
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
Also known as: brain-computer interface, neuroprosthetic
Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG
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.
Time frame: Up to 29 days of device implantation
Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System
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.
Time frame: Up to 29 days of device implantation
Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations
| Milestone | Direct Brain Interface Users |
|---|---|
| Started | 6 |
| First (1st implanted) subject enrolled | 1 |
| Second subject enrolled | 1 |
| Third subject enrolled | 1 |
| Fourth subject enrolled | 1 |
| Fifth (2nd implanted) subject enrolled | 1 |
| Sixth (3rd implanted) subject | 1 |
| Completed | 3 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Determined ineligible during screening. | 2 |
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.
| participants | Direct Brain Interface Users |
|---|---|
| Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG | 3 |
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.
| participants | Direct Brain Interface Users |
|---|---|
| Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System | 3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Direct Brain Interface Users | — | 0/6 (0%) | 1/6 (16.7%) |
| Event | Direct Brain Interface Users |
|---|---|
| Neck pain following implant surgeryMusculoskeletal and connective tissue disorders | 1/6 |
All individuals were English speaking, with a disability of at least one hand/arm, but no other health issues which would interfere with or be made worse by study participation.
| Age, Categorical(Participants) | Direct Brain Interface Users |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age, Continuous(years) | Direct Brain Interface Users |
|---|---|
| Mean | 39 (20 to 54) |
| Sex: Female, Male(Participants) | Direct Brain Interface Users |
|---|---|
| Female | 1 |
| Male | 5 |
| Region of Enrollment(participants) | Direct Brain Interface Users |
|---|---|
| United States | 6 |
Plan to share: Yes — Study sponsors, as well as the FDA, will have access to research data and documents in order to monitor the integrity of the study.
The record gives a start of May 2011, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2016, 1 year 8 months after primary completion.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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