Measuring Plasticity in SFC/dACC Following Theta-Burst-Stimulation Using TMS (BTMS)
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|ClinicalTrials.gov Identifier: NCT03946059|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Control||Device: rTMS - iTBS Device: rTMS - cTBS||Early Phase 1|
- Brain/Behavior Recordings: to measure brain activity as described above, the investigators will first ask subjects to engage in a cognitive battery while measuring EEG activity. For this study, the battery consists of the following tasks: (1) a go/no-go task to study sustained attention and behavioral inhibition; (2) a visuo-spatial working-memory task; (3) a Flanker interference task and (4) a emotional-distractor task. A breath monitoring task is also included as a measure of internal attention/distraction. This battery takes about 30 minutes to complete. 24 channel EEG recordings will be performed during this task. Subjects will perform BrainE, will receive brain-stimulation, and will then immediately be tested on the BrainE tasks again.
- 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 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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The investigators will test the effects of two different interventions (iTBS, cTBS) on cognitive control. Each participant will receive both interventions, labeled A & B, separated a week apart.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Investigators will assess for each subject whether they have any guess, a priori, as to hypothesized effects of the interventions (improve, impair or no change on cognition). Participant/care provider will know which stimulation is being applied (iTBS, cTBS based on labels A & B), but will not know the hypothesized effects of these two interventions. Interventions will be masked as "treatment A" and "treatment B", prior to handing the data over to PI/outcomes assessor. Analyses will thus be performed to assess whether treatment "A" or treatment "B" has an effect on cognition; and whether there are differences between these treatments. After the trial is finished, treatments will be un-masked.|
|Primary Purpose:||Basic Science|
|Official Title:||Estimating the Sensitivity of a Mobile Neuro-cognitive Platform ("BrainE") to Detect Neural Plasticity and Cognitive Enhancements Following Theta-burst Stimulation to Superior Frontal/dACC TMS Stimulation.|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Experimental: iTBS over superior frontal cortex
intermittent Theta-Burst-Stimulation (iTBS) entails a 2 second train of stimuli (stimuli occurring as a 50 Hz burst of three pulses separated by 200ms). Each 2 second train is followed by an 8 second pause, followed by another 2 second train. In total, 20 trains will be delivered, for a total of 200 bursts and 600 total pulses.
Device: rTMS - iTBS
repetitive transcranial magnetic stimulation applied with intermittent theta-burst stimulation protocol
Active Comparator: cTBS over superior frontal cortex
continuous Theta-Burst-Stimulation (cTBS) consists of a continuous stimulus train (stimuli occurring as a 50 Hz burst of three pulses separated by 200ms). In total, 200 bursts and 600 total pulses will be delivered.
Device: rTMS - cTBS
repetitive transcranial magnetic stimulation applied with continuous theta-burst stimulation protocol
- Changes in mid-frontal theta oscillations [ Time Frame: immediately before and immediately after the intervention on the same day ]Changes in frontal task-evoked theta oscillations across four cognitive tasks.
- Changes in cognitive performance [ Time Frame: immediately before and immediately after the intervention on the same day ]Changes in performance efficiency (ratio of accuracy to response time) on tested cognitive tasks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946059
|Contact: Jyoti Mishra, PhDfirstname.lastname@example.org|
|United States, California|
|Altman Clinical & Translational Research Institute||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Jyoti Mishra, PhD 858-822-0568 email@example.com|
|Principal Investigator:||Jyoti Mishra, PhD||University of California, San Diego|