Epilepsy IntractableNCT03289572
Microgrid II - Electrocorticography Signals for Human Hand Prosthetics
An observational study of Epilepsy Intractable, run by University of Washington at 1 site in United States.
Trial summary
Neurologic disease with loss of motor function is a major health burden. Brain-computer interfaces (BCI) are systems that use brain signals to power an external device, such as a communication board or a prosthetic device, which may help people with loss of motor function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy Intractable
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intractable epilepsy ages 18 and above scheduled to undergo grid placement for epilepsy treatment.
Who may be able to join
- Must be able to speak and read English
- Cognitive ability to follow study directions
- Patients that are scheduled to undergo grid placement clinically for treatment of
- intractable epilepsy
- 18 years of age or older
Who cannot join
- Patients who are not considered candidates for epilepsy surgery
- Individuals who have a diagnosis that would not allow them to participate in research procedures. For example, a physical disability that would limit hand movements and range of motion.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
Amy Anderson, 206-744-9364, amya9@uw.edu
Jeffrey G Ojemann, MD
About this study
Neurologic disease with loss of motor function is a major health burden. Brain-computer interfaces (BCI) are systems that use brain signals to power an external device, such as a communication board or a prosthetic device, which may help people with loss of motor function. Electrocorticography (ECoG) has been used to decode hand movements and as a control signal for brain-computer interface (BCI). This study hopes to use a smaller spacing of ECoG to see if a better motor signal can be found and used as a BCI control signal.
Read the detailed description
Stroke, spinal cord injury, extremity injury and degenerative/locked-in syndromes are among those conditions that may benefit from sustainable neuroprosthetic options. The investigators have studied human motor cortex and related cortical areas with direct brain recording (electrocorticography or ECoG) as a signal for motor neuroprosthetics. Completing exciting studies in humans with local fields using intracortical electrodes and long-term working brain-computer interfaces with EEG, electrocorticography surveys an intermediate level of spatial specificity and may have durability in long-term recordings. ECoG signals could ultimately be obtained epidurally or even more superficially if the exact signals were better understood. To date, the investigators have demonstrated that ECoG signals from motor cortex can be used to decode movement and have a precision using clinic arrays (1 cm resolution) that can decode hand movement and allow for the separation of digit movement. These signals have been used for brain-computer interface and can be used to control a prosthetic hand in humans.
Electrocorticography (ECoG) is the recording of brain signals directly from the cortical surface. In patients undergoing surgical treatment of epilepsy, these signals have been available and have shown to be rich sources of motor-related signals that can drive a hand neuroprosthetic as part of a brain-computer interface (BCI). Though the clinically available resolution of 1 cm allows for separation of different types of finger movement by using the high-frequency characteristics of the ECoG recording (70-100Hz), higher spatial resolutions (3mm) increases the ability to decode finger movements and more complicated hand movements, such as grasping of different objects. Ideal resolution is one of the several gaps in knowledge limit pursuing implementation of ECoG-based BCI along with uncertainty about the longevity of ECoG signals and human implementation of feedback directly to cortex through electrical stimulation.
Specific Aim:
Higher resolution arrays over subacute (1 week) time frame to allow for adaptation and BCI use of the higher resolution signals. An 8x8 array of 3mm resolution will be placed over sensorimotor cortex. Grasp synergies will be determined and mapped onto the electrodes to determine control channels for each synergy. Control of multiple synergies will move a simulated robotic hand to a visually cued target shape
- Hand synergies will be independently mapped onto the 3mm x 3mm (microarray) with at least one independent electrode for each of the first three synergies
- Using the signals from the microarray, participants will correctly move the robotic hand into one of 6 target postures with 50% accuracy.
- Conditions
- Epilepsy Intractable
- Medical subject headings
- Drug Resistant Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
This is an observational study and the outcome is successful measurement of motor-related corticography signals.
Successful measurement of motor-related corticography signals
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study startNov 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Ojemann, University of Washington
- Investigators
- Jeffrey G Ojemann, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289572
- Sponsor's protocol ID
- STUDY00003073
- Status last verified
- Apr 2021
- First submitted
- 15 Sep 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microgrid II - Electrocorticography Signals for Human Hand Prosthetics
- ClinicalTrials.gov ID
- NCT03289572
- Acronym / sponsor ID
- STUDY00003073
- Conditions
- Epilepsy Intractable
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurologic disease with loss of motor function is a major health burden. Brain-computer interfaces (BCI) are systems that use brain signals to power an external device, such as a communication board or a prosthetic device, which may help people with loss of motor function. Electrocorticography (ECoG) has been used to decode hand movements and as a control signal for brain-computer interface (BCI). This study hopes to use a smaller spacing of ECoG to see if a better motor signal can be found and used as a BCI control signal.
Detailed description
Stroke, spinal cord injury, extremity injury and degenerative/locked-in syndromes are among those conditions that may benefit from sustainable neuroprosthetic options. The investigators have studied human motor cortex and related cortical areas with direct brain recording (electrocorticography or ECoG) as a signal for motor neuroprosthetics. Completing exciting studies in humans with local fields using intracortical electrodes and long-term working brain-computer interfaces with EEG, electrocorticography surveys an intermediate level of spatial specificity and may have durability in long-term recordings. ECoG signals could ultimately be obtained epidurally or even more superficially if the exact signals were better understood. To date, the investigators have demonstrated that ECoG signals from motor cortex can be used to decode movement and have a precision using clinic arrays (1 cm resolution) that can decode hand movement and allow for the separation of digit movement. These signals have been used for brain-computer interface and can be used to control a prosthetic hand in humans.
Electrocorticography (ECoG) is the recording of brain signals directly from the cortical surface. In patients undergoing surgical treatment of epilepsy, these signals have been available and have shown to be rich sources of motor-related signals that can drive a hand neuroprosthetic as part of a brain-computer interface (BCI). Though the clinically available resolution of 1 cm allows for separation of different types of finger movement by using the high-frequency characteristics of the ECoG recording (70-100Hz), higher spatial resolutions (3mm) increases the ability to decode finger movements and more complicated hand movements, such as grasping of different objects. Ideal resolution is one of the several gaps in knowledge limit pursuing implementation of ECoG-based BCI along with uncertainty about the longevity of ECoG signals and human implementation of feedback directly to cortex through electrical stimulation.
Specific Aim:
Higher resolution arrays over subacute (1 week) time frame to allow for adaptation and BCI use of the higher resolution signals. An 8x8 array of 3mm resolution will be placed over sensorimotor cortex. Grasp synergies will be determined and mapped onto the electrodes to determine control channels for each synergy. Control of multiple synergies will move a simulated robotic hand to a visually cued target shape
- Hand synergies will be independently mapped onto the 3mm x 3mm (microarray) with at least one independent electrode for each of the first three synergies
- Using the signals from the microarray, participants will correctly move the robotic hand into one of 6 target postures with 50% accuracy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intractable epilepsy ages 18 and above scheduled to undergo grid placement for epilepsy treatment.
Key inclusion criteria (5 listed)
- Must be able to speak and read English
- Cognitive ability to follow study directions
- Patients that are scheduled to undergo grid placement clinically for treatment of
- intractable epilepsy
- 18 years of age or older
Key exclusion criteria (2 listed)
- Patients who are not considered candidates for epilepsy surgery
- Individuals who have a diagnosis that would not allow them to participate in research procedures. For example, a physical disability that would limit hand movements and range of motion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This is an observational study and the outcome is successful measurement of motor-related corticography signals.
Time frame: 7-10 days
Successful measurement of motor-related corticography signals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Epilepsy Intractable
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
RecruitingObservational study
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
Perinatal Stroke, Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
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.
Jeffrey G Ojemann, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy Intractable, run by University of Washington 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy m Anderson, BSN (206-744-9364, amya9@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is an observational study and the outcome is successful measurement of motor-related corticography signals. (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2021.