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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
  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: U.S.-German Collaboration: Optimization of Human Cortical Stimulation

Resource links provided by NLM:


Further study details as provided by Jeffrey Ojemann, University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Evaluate distribution of current from stimulation [ Time Frame: 5 years ]
    Using mathematical models to determine if current is going to areas expected


Estimated Enrollment: 8
Study Start Date: September 2010
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2020 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.
Criteria

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
Information from the National Library of Medicine

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


Contacts
Contact: Jeffrey G Ojemann, MD 206-987-4240 jojemann@u.washington.edu
Contact: Eberhard E Fetz, PhD 206-543-4839 fetz@u.washington.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Amy Anderson    206-744-9364    amya9@uw.edu   
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         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jeffrey G Ojemann, MD University of Washington
  More Information

Additional Information:
Responsible Party: Jeffrey Ojemann, Professor, Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT01198964     History of Changes
Other Study ID Numbers: STUDY00001800
First Submitted: September 8, 2010
First Posted: September 10, 2010
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Jeffrey Ojemann, University of Washington:
ECoG
Epilepsy
cortical
stimulation
Electrocorticography
electrodes
mapping

Additional relevant MeSH terms:
Brain Injuries
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries