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Optimization of Human Cortical Stimulation (BCI)

This study is currently recruiting participants.
Verified May 2017 by Jeffrey Ojemann, University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198964
First Posted: September 10, 2010
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
Jeffrey Ojemann, University of Washington
September 8, 2010
September 10, 2010
May 30, 2017
September 2010
August 2020   (Final data collection date for primary outcome measure)
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.
Link EMG activity produced during a motor task to stimulation of a part of the brain [ Time Frame: 3 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.
Complete list of historical versions of study NCT01198964 on ClinicalTrials.gov Archive Site
Evaluate distribution of current from stimulation [ Time Frame: 5 years ]
Using mathematical models to determine if current is going to areas expected
Test whether the language system can show stimulation-induced plasticity when stimulation is conditional on language processing [ Time Frame: 3 years ]
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.
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Optimization of Human Cortical Stimulation
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.
  • Epilepsy
  • Brain Injury
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.
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.
Intervention: Procedure: Low-level cortical stimulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
August 2021
August 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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
 
 
NCT01198964
STUDY00001800
No
Not Provided
Not Provided
Jeffrey Ojemann, University of Washington
University of Washington
Not Provided
Principal Investigator: Jeffrey G Ojemann, MD University of Washington
University of Washington
May 2017