Brain Computer Interfaces for Functional Recovery From Brain Injury (BCI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Life Sciences Discovery Fund
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01198964
First received: September 8, 2010
Last updated: October 20, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: 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         
Sponsors and Collaborators
University of Washington
Life Sciences Discovery Fund
Investigators
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
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 19, 2014