EEG, TMS
Conditions
Brief summary
The current study presents a unique opportunity to measure the direct effects of transcranial magnetic stimulation (TMS) by using intracranial electrodes to record neural activity in deep brain regions when TMS single pulses are delivered. If TMS can evoke downstream responses in neural networks of the human brain, it can be a feasible way to study circuit engagement and connectivity.
Interventions
DEVICESingle Pulse TMS
single pulse TMS will be administered when participants have intracranial electrodes implanted to measure neuronal activity.
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 a TMS session while implanted with electrodes.
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 neurological and/or psychiatric conditions at Pennsylvania Hospital 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 who are unable to have an MRI scan 3. Patients who are unable to tolerate TMS 4. Patients with additional implanted devices, such as an aneurysm clip or a cardiac pacemaker, that would increase the TMS risk profile 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 | Description |
|---|---|---|
| Primary Endpoint #1 Brain Activity and Connectivity | From enrollment to the end of study participation at 5 weeks | Observation of effects in brain activity and connectivity within and across regions of interest before and after TMS, as measured by intracranial EEG. The evoked response magnitude from the EEG at all features of the time-frequency analysis are used. |
| Primary Endpoint #2: Safety Feasibility | From enrollment to end of study participation at 5 weeks. | Safety, as defined by the number of adverse events (AE) |
Countries
United States
Outcome results
None listed