Optimization of Human Cortical Stimulation (BCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01198964|
Recruitment Status : Recruiting
First Posted : September 10, 2010
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment|
|Epilepsy Brain Injury||Procedure: Low-level cortical stimulation|
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 Type :||Observational|
|Estimated Enrollment :||8 participants|
|Official Title:||U.S.-German Collaboration: Optimization of Human Cortical Stimulation|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
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.
- 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.
- Evaluate distribution of current from stimulation [ Time Frame: 5 years ]Using mathematical models to determine if current is going to areas expected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198964
|Contact: Jeffrey G Ojemann, MDfirstname.lastname@example.org|
|Contact: Eberhard E Fetz, PhDemail@example.com|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Amy Anderson 206-744-9364 firstname.lastname@example.org|
|Principal Investigator: Jeffrey G Ojemann, MD|
|Sub-Investigator: Shahin Hakimian, MD|
|Sub-Investigator: John Miller, MD, PHD|
|Sub-Investigator: Mark Holmes, MD|
|Sub-Investigator: Andrew Ko, MD|
|Principal Investigator:||Jeffrey G Ojemann, MD||University of Washington|