Optimization of Human Cortical Stimulation

NCT ID: NCT01198964

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2023-08-31

Brief Summary

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.

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.

Conditions

Epilepsy; Brain Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Low-level cortical stimulation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Ojemann

Professor, Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey G Ojemann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey G Ojemann, MD

Role: CONTACT

jojemann@u.washington.edu

206-987-4240

Eberhard E Fetz, PhD

Role: CONTACT

fetz@u.washington.edu

206-543-4839

Facility Contacts

Amy Anderson

Role: primary

amya9@uw.edu

206-744-9364

Related Links

http://pcs.hmc.washington.edu/epilepsy/

Home page for Harborview's Regional Epilepsy Center

Other Identifiers

STUDY00001800

Identifier Type: -

Identifier Source: org_study_id