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Optimization of Human Cortical Stimulation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01198964
Acronym
BCI
Enrollment
8
Registered
2010-09-10
Start date
2010-09-30
Completion date
2023-08-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Epilepsy

Keywords

ECoG, Epilepsy, cortical, stimulation, Electrocorticography, electrodes, mapping

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.

Interventions

PROCEDURELow-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.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Link EMG activity produced during a motor task to stimulation of a part of the brain5 yearsAttempt 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

MeasureTime frameDescription
Evaluate distribution of current from stimulation5 yearsUsing mathematical models to determine if current is going to areas expected

Countries

United States

Contacts

Primary ContactJeffrey G Ojemann, MD
jojemann@u.washington.edu206-987-4240
Backup ContactEberhard E Fetz, PhD
fetz@u.washington.edu206-543-4839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026