Optimization of Human Cortical Stimulation

Epilepsy Clinical Trial

— BCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198964
• Other study ID #: STUDY00001800
• Status: Recruiting
• Start date: September 2010
• Est. completion date: August 2023

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: Jeffrey G Ojemann, MD
• Phone: 206-987-4240
• Email: jojemann[@]u.washington.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate distribution of current from stimulation	Using mathematical models to determine if current is going to areas expected	5 years

External Links

•   Home page for Harborview's Regional Epilepsy Center