Optimization of Human Cortical Stimulation

• Conditions: Epilepsy; Brain Injury
• Interventions: Procedure: Low-level cortical stimulation

• Registration Number: NCT01198964
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Age 18 and older
• Male and Female
• Able to understand English for consenting and testing
• Referred for surgical implantation of electrodes

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Exclusion Criteria

• Under 18 years of age
• Pregnant women
• Prisoners
• Mentally disabled IQ < 70
• Non English Speaking
• Not candidates for surgical implantation of electrodes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epileptic Patients	Low-level cortical stimulation	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.

Primary Outcome Measures

Name	Time	Method
Link EMG activity produced during a motor task to stimulation of a part of the brain	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

Name	Time	Method
Evaluate distribution of current from stimulation	5 years	Using mathematical models to determine if current is going to areas expected

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States