TetraplegiaNCT01393444
ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
A study testing Implantation of ECoG sensors on the brain surface in people with Tetraplegia and Spinal Cord Injury, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tetraplegia, Spinal Cord Injury, Brachial Plexus Injury
- What is being tested?
- Implantation of ECoG sensors on the brain surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis
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.
Read the 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.
- Conditions
- Tetraplegia, Spinal Cord Injury, Brachial Plexus Injury, Muscular Dystrophy, ALS, Brainstem Stroke
- Being tested
- Implantation of ECoG sensors on the brain surface
- Keywords
- Electrocorticography, Tetraplegia, Spinal cord injury, Brainstem stroke, Neuroprosthetic, Brain-computer interface, Direct brain interface, Neural activity, Motor cortex
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries, Muscular Dystrophies, Brain Stem Infarctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of ECoG sensors on the brain surfaceDevice
Also called brain-computer interface, neuroprosthetic
One ECoG sensor will be implanted over the motor cortex of study participants
| Study group | Role | What they receive |
|---|---|---|
| Direct Brain Interface Users | Experimental | 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. Receives: Device: Implantation of ECoG sensors on the brain surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 29 days of device implantation
Secondary outcomes (1)
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.
Measured: Up to 29 days of device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Collinger, PhD, University of Pittsburgh
- Investigators
- Jennifer L Collinger, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393444
- Sponsor's protocol ID
- PRO10010149
- Status last verified
- Oct 2016
- First submitted
- 11 Jul 2011
- Last updated
- 12 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
Publications
Degenhart AD, Hiremath SV, Yang Y, Foldes S, Collinger JL, Boninger M, Tyler-Kabara EC, Wang W. Remapping cortical modulation for electrocorticographic brain-computer interfaces: a somatotopy-based approach in individuals with upper-limb paralysis. J Neural Eng. 2018 Apr;15(2):026021. doi: 10.1088/1741-2552/aa9bfb.
PubMed 29160240
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis
- ClinicalTrials.gov ID
- NCT01393444
- Acronym / sponsor ID
- PRO10010149
- Conditions
- Tetraplegia, Spinal Cord Injury, Brachial Plexus Injury, Muscular Dystrophy, ALS, Brainstem Stroke
- Keywords
- Electrocorticography, Tetraplegia, Spinal cord injury, Brainstem stroke, Neuroprosthetic, Brain-computer interface, Direct brain interface, Neural activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Brain Interface Users | Experimental | Device: Implantation of ECoG sensors on the brain surfaceAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of ECoG sensors on the brain surfaceAlso: brain-computer interface, neuroprostheticOne ECoG sensor will be implanted over the motor cortex of study participants | Device | Direct Brain Interface Users |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29160240Degenhart AD, Hiremath SV, Yang Y, Foldes S, Collinger JL, Boninger M, Tyler-Kabara EC, Wang W. Remapping cortical modulation for electrocorticographic brain-computer interfaces: a somatotopy-based approach in individuals with upper-limb paralysis. J Neural Eng. 2018 Apr;15(2):026021. doi: 10.1088/1741-2552/aa9bfb.
- Brain Computer Interface Research at University of Pittsburgh Medical Center (UPMC) / University of PittsburghLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Tetraplegia
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Collinger, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of ECoG sensors on the brain surface in people with Tetraplegia and Spinal Cord Injury, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.