N/A
N=25
Measuring Plasticity in SFC/dACC Following Theta-Burst-Stimulation Using TMS
Cognitive Control
Bottom Line
View on ClinicalTrials.gov: NCT03946059 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation — -0.043; 0.017 microVolts (uV) at FCz EEG electrode
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iTBS then cTBS (Device); cTBS then iTBS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation |
-0.043; 0.017 | — |
| SECONDARY Post vs. Pre Change in Cognitive Performance |
0.025; 0.013 | — |
Summary
This is a study to determine whether particular forms of brain-stimulation, applied to superior frontal cortex/preSMA can affect cognition and associated frontal theta oscillations. To perform this study, the investigators first measure brain activity and cognitive performance using "BrainE", a cognitive task platform that assesses cognition on sustained attention, response inhibition, working memory, interference processing and emotion processing assessments. Next, the investigators apply brain-stimulation over a mid-frontal region associated with these tasks (mid-line frontal activity overlying superior frontal cortex/pre-SMA area). Finally, human subjects perform the "BrainE" task assessments again immediately after the brain-stimulation. The investigators compare the effects of brain stimulation on average frontal activity evoked across the cognitive tasks, and on the cognitive performance averaged across tasks. The investigators primarily compare the effects of two types of brain-stimulation against each other: intermittent Theta-Burst Stimulation (a protocol designed to excite brain activity) and continuous Theta-Burst-Stimulation (a stimulation protocol designed to inhibit brain activity).
Eligibility Criteria
Inclusion Criteria
Adequate decisional capacity to make a choice about participating in this research study.
Exclusion Criteria
- No major active neurologic/psychiatric disease
- No contraindications for rTMS
- No behavioral/medical factors that increase risk of seizure
Data sourced from ClinicalTrials.gov (NCT03946059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.