Electrodes, Implanted, Low Intensity Focussed Ultrasound
Conditions
Brief summary
The current study presents a unique opportunity to measure the immediate neural responses to brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses using intracranial electrodes. By recording time-locked signals in local and distant brain regions we can characterize circuit connectivity in real-time. We will use adult patients undergoing intracranial electrophysiological monitoring in an inpatient setting as our targeted population.
Interventions
The study visit consists of non-therapeutic transcranial low-intensity focused ultrasound pulses given while patient has intracranial electrodes implanted.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Adult Patients undergoing intracranial electrophysiological monitoring in an inpatient setting are invited to participate in the one session of LIFU
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who received (or are scheduled to receive) intracranial electrode implantation surgery as part of standard clinical care or as participation in an ongoing research study for the treatment of epilepsy and/or neuropsychiatric conditions at Pennsylvania Hospital (PAH) or Hospital of the University of Pennsylvania (HUP). 2. Adult patients, 21 to 75 years of age 3. Patients considered to be in a stable medical condition, in the opinion of the PI 4. Patients who are able to demonstrate comprehension of instructions in the English language, in the opinion of the PI 5. Patients who are able to provide informed consent and fully comply with all study requirements, in the opinion of the PI
Exclusion criteria
1. Patients with chronic alcohol abuse history 2. Patients with additional implanted devices, such as an aneurysm clip, large cranial plates or mesh that may intersect with ultrasonic beam path 3. Open scalp wounds, infection or dermatologic condition that preclude safe placement of ultrasound transducer 4. Intracranial mass lesion with significant mass effect near intended beam path 5. Patients who are pregnant at the time of screening or patients who get pregnant during the course of the study 6. Patients with any past or present medical condition, disease, disorder, or injury that, in the opinion of the PI, may reduce or hinder the participant's ability to fully comply with all study requirements or may impact, compromise, or affect the integrity of the data or the results of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local spectral responses and temporally linked network activity, as measured by intracranial EEG | From enrollment to end of study is two weeks |
| Safety, as defined by the number and type of adverse events (AE) and change in clinical VAS scales | From enrollment to end of study is 2 weeks |
Countries
United States
Outcome results
None listed