Optimization of Human Cortical Stimulation (BCI)

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Brain Injury
• Intervention / Treatment: Procedure: Low-level cortical stimulation

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.

• Study Type: Observational
• Enrollment (Anticipated): 8

Contacts and Locations

• Study Contact: Name: Jeffrey G Ojemann, MD; Phone Number: 206-987-4240; Email: jojemann@u.washington.edu
• Study Contact Backup: Name: Eberhard E Fetz, PhD; Phone Number: 206-543-4839; Email: fetz@u.washington.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age 18 and older male and female epileptic patients who are referred for surgical implantation of electrodes.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Link EMG activity produced during a motor task to stimulation of a part of the brain	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate distribution of current from stimulation	Using mathematical models to determine if current is going to areas expected	5 years

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Jeffrey G Ojemann, MD, University of Washington

Publications and helpful links

Helpful Links

• Home page for Harborview's Regional Epilepsy Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Epilepsy; stimulation; electrodes; Electrocorticography; mapping; ECoG; cortical
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Epilepsy; Brain Injuries
• Other Study ID Numbers: STUDY00001800