Brain Computer Interfaces for Functional Recovery From Brain Injury (BCI)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epilepsy Brain Injury |
Procedure: Low-level cortical stimulation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Brain Computer Interfaces for Functional Recovery From Brain Injury |
- Link EMG activity produced during a motor task to stimulation of a part of the brain [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
- Test whether the language system can show stimulation-induced plasticity when stimulation is conditional on language processing [ Time Frame: 3 years ] [ Designated as safety issue: No ]The parallel analogies to the motor experiments will be attemps at language production substituting for movement and, secondly, electrocortical activity at language sites substituing for motor sites.
| Estimated Enrollment: | 8 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Low-level cortical stimulation
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.
Inclusion Criteria:
- Age 18 and older
- Male and Female
- Able to understand English for consenting and testing
- Referred for surgical implantation of electrodes
Exclusion Criteria:
- Under 18 years of age
- Pregnant women
- Prisoners
- Mentally disabled IQ < 70
- Non English Speaking
- Not candidates for surgical implantation of electrodes
Contacts and Locations| Contact: Jeffrey G Ojemann, MD | 206-987-4240 | jojemann@u.washington.edu |
| Contact: Eberhard E Fetz, PhD | 206-543-4839 | fetz@u.washington.edu |
| United States, Washington | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Alana C Clark, BA 206-744-9364 alanac@uw.edu | |
| Principal Investigator: Jeffrey G Ojemann, MD | |
| Sub-Investigator: Shahin Hakimian, MD | |
| Sub-Investigator: Stravros Zanos, MD | |
| Sub-Investigator: John Miller, MD, PHD | |
| Sub-Investigator: Mark Holmes, MD | |
| Sub-Investigator: Adam Hebb, MD | |
| Sub-Investigator: Matthew Edwardson, MD | |
| Principal Investigator: | Jeffrey G Ojemann, MD | University of Washington |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jeffrey Ojemann, M.D., University of Washington |
| ClinicalTrials.gov Identifier: | NCT01198964 History of Changes |
| Other Study ID Numbers: | 37183-D |
| Study First Received: | September 8, 2010 |
| Last Updated: | October 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
ECoG Epilepsy cortical stimulation |
Electrocorticography electrodes mapping |
Additional relevant MeSH terms:
|
Epilepsy Brain Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013