BCI: Optimization of Human Cortical Stimulation

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT01198964

Collaborator

(none)

Enrollment

Location

155

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Brain Injury	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 Design

Study Type:

Observational

Anticipated Enrollment :

8 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.