A Study to Evaluate Brain Computer Interface (BCI) and Electrocorticography (ECoG)- based Mapping of Sensori-motor and Language Modalities Utilizing Subdural Electrodes in the Human Brain
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-011810
Sponsor Protocol Number: 18-011810
About this study
The purpose of this study is to advance our understanding of the connectivity, causal role, and dynamic modulation of inter-areal communication in the human brain by recording electrocorticographic (ECoG) and stereoencephalographic (SEEG) brain signals during visual, auditory and sensory-motor tasks in patients awaiting invasive brain surgery with a particular focus on cortical networks engaged in perception of speech, language, and music.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients recruited for this project will be those individuals with intractable epilepsy requiring placement of intracranial electrodes (grid, strip, or depth types) for localization of seizure focus.
- Number of patients based on current projections is estimated to be ~6/year at current clinical volumes.
Exclusion Criteria:
- Patients who are unable to execute the motor/imagined tasks outlined above. This will include those individuals with mental retardation (IQ <70), language disabilities, significant visual loss, and others with cognitive impairments. Since inception of this type of recording analysis in 2002 through to the present, all candidates who have undergone conventional resective epilepsy surgery requiring implanted electrodes, in retrospect, would have met the inclusion criteria for the present proposed study.
- Therefore, the inclusion/exclusion criteria are not expected to have a negative influence on recruitment.
- The estimate of 6 cases is based on an estimate of surgical volume projected from a 2017 & 2018 review of epilepsy surgery volume (Mayo Jacksonville).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Anteneh Feyissa, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available