Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03946059 |
| Other study ID # |
BrainE_TMS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2019 |
| Est. completion date |
October 30, 2019 |
Study information
| Verified date |
February 2021 |
| Source |
University of California, San Diego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
1. Brain/Behavior Recordings: to measure brain activity as described above, the
investigators first ask subjects to engage in a cognitive assessment set while measuring
EEG activity. For this study, the assessment set consists of the following tasks: (1)
sustained attention; (2) response inhibition; (2) visuo-spatial working-memory; (3)
Flanker interference processing, and (4) emotional interference processing. This battery
takes about 30 minutes to complete. 24 channel EEG recordings are performed simultaneous
to the cognitive tasks. Subjects perform the "BrainE" cognitive assessment, then receive
brain-stimulation, and will then immediately be tested on the BrainE assessment again.
2. Brain-Stimulation: Each subject will be asked to come in twice for this study, separated
by 1 week. On week one they will receive one stimulation protocol, and on the subsequent
week they will receive the other (order determined randomly for each subject). The
intermittent Theta-Burst-Stimulation protocol (iTBS) consists of a similar burst pattern
(3 stimulation pulses 20ms apart; each burst applied every 200ms). However, after 10
bursts (2 seconds of stimulation) there is a pause for 8 seconds. 200 bursts are still
applied, however due to the inter-burst intervals, this paradigm takes 200 seconds. The
continuous Theta-Burst-Stimulation protocol (cTBS) consists of a burst of three
stimulation pulses, applied 20ms apart; with each burst occurring every 200ms. Thus,
every second participants receive 5 bursts. This continues for 40 seconds, such that
participants in total receive 200 bursts or 600 pulses.
