EpilepsyBCINCT01198964
Optimization of Human Cortical Stimulation
An observational study of Epilepsy and Brain Injury, run by University of Washington at 1 site in United States.
Trial summary
We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Brain Injury
- What is being tested?
- Low-level cortical stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2023
- 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: Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.
Who may be able to join
- Age 18 and older
- Male and Female
- Able to understand English for consenting and testing
- Referred for surgical implantation of electrodes
Who cannot join
- Under 18 years of age
- Pregnant women
- Prisoners
- Mentally disabled IQ < 70
- Non English Speaking
- Not candidates for surgical implantation of electrodes
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
Official title: U.S.-German Collaboration: Optimization of Human Cortical Stimulation
We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.
Read the detailed description
The subject will have already been scheduled for placement of the ECoG electrodes on the surface of the brain and who will, for all clinical purposes, subsequently receive stimulation for mapping of function of the ECoG sites. The decision to place the electrodes on the brain, the location of the electrodes and the length of time the electrodes are in are all part of clinical care.
There will be two types of testing, motor and language. Motor will involve inducing stimulation to the thumb cortex and the wrist cortex. There will be a conditioning of this over 4-12 hours. Language will involve showing pictures on a computer screen and the subject will be observed whether speech is disrupted with stimulation or not.
- Conditions
- Epilepsy, Brain Injury
- Being tested
- Low-level cortical stimulation
- Keywords
- ECoG, Epilepsy, cortical, stimulation, Electrocorticography, electrodes, mapping
- Medical subject headings
- Epilepsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level cortical stimulationProcedure or surgery
A couple of electrodes will be stimulated (at a lower level than the stimulation used for standard care) over a period of 4-12 hours based on the signals defined by the motor or language task.
| Study group | Role | What they receive |
|---|---|---|
| Epileptic Patients | The population of patients with medically refractory epilepsy will already have been recommended clinically for electrode grid placement on the brain and high-level stimulation to map brain function. Receives: Procedure: Low-level cortical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Link EMG activity produced during a motor task to stimulation of a part of the brain
Attempt to link EMG activity produced during a motor task to stimulation of a part of the brain nearby, but distinct from, the part of the brain normally used to perform the task.
Measured: 5 years
Secondary outcomes (1)
Evaluate distribution of current from stimulation
Using mathematical models to determine if current is going to areas expected
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- 8 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
- NCT01198964
- Sponsor's protocol ID
- STUDY00001800
- Acronym
- BCI
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2010
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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
- U.S.-German Collaboration: Optimization of Human Cortical Stimulation
- ClinicalTrials.gov ID
- NCT01198964
- Acronym / sponsor ID
- BCI / STUDY00001800
- Conditions
- Epilepsy, Brain Injury
- Keywords
- ECoG, Epilepsy, cortical, stimulation, Electrocorticography, electrodes, mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 10 Sep 2010 (estimated)
- 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.
We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.
Detailed description
The subject will have already been scheduled for placement of the ECoG electrodes on the surface of the brain and who will, for all clinical purposes, subsequently receive stimulation for mapping of function of the ECoG sites. The decision to place the electrodes on the brain, the location of the electrodes and the length of time the electrodes are in are all part of clinical care.
There will be two types of testing, motor and language. Motor will involve inducing stimulation to the thumb cortex and the wrist cortex. There will be a conditioning of this over 4-12 hours. Language will involve showing pictures on a computer screen and the subject will be observed whether speech is disrupted with stimulation or not.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic Patients | – | Procedure: Low-level cortical stimulationThe population of patients with medically refractory epilepsy will already have been recommended clinically for electrode grid placement on the brain and high-level stimulation to map brain function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.
Key inclusion criteria (4 listed)
- Age 18 and older
- Male and Female
- Able to understand English for consenting and testing
- Referred for surgical implantation of electrodes
Key exclusion criteria (6 listed)
- Under 18 years of age
- Pregnant women
- Prisoners
- Mentally disabled IQ < 70
- Non English Speaking
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 |
|---|---|---|
| Low-level cortical stimulationA couple of electrodes will be stimulated (at a lower level than the stimulation used for standard care) over a period of 4-12 hours based on the signals defined by the motor or language task. | Procedure or surgery | Epileptic Patients |
Primary outcome
Link EMG activity produced during a motor task to stimulation of a part of the brain
Time frame: 5 years
Attempt to link EMG activity produced during a motor task to stimulation of a part of the brain nearby, but distinct from, the part of the brain normally used to perform the task.
1 secondary outcome
Evaluate distribution of current from stimulation
Time frame: 5 years
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.
- Home page for Harborview's Regional Epilepsy CenterLink provided by the sponsor.
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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 and Brain Injury, 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 4 inclusion and 6 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 Jeffrey G Ojemann, MD (206-987-4240, jojemann@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Link EMG activity produced during a motor task to stimulation of a part of the brain (time frame: 5 years). 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.