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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
Sponsor:
Information provided by (Responsible Party):
Jyoti Mishra, University of California, San Diego

Brief 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 will first measure brain activity/cognitive performance using "BrainE", a rapid series of cognitive tests measuring sustained attention, behavioral inhibition, working memory and interference/distractor processing. Next, the investigators will apply brain-stimulation over a mid-frontal region most strongly associated with these tasks (mid-line frontal activity overlying superior frontal cortex/pre-SMA area). Finally, human subjects will perform BrainE assessments again immediately after the brain-stimulation. The investigators will compare the effects of brain stimulation on frontal activity evoked on the cognitive tasks, and on behavioral performance across these tasks. The investigators will further compare two types of brain-stimulation against each other: continuous Theta-Burst-Stimulation (a stimulation protocol designed to inhibit brain activity) and intermittent Theta-Burst Stimulation (a protocol designed to excite brain activity).

Condition or disease Intervention/treatment Phase
Cognitive Control Device: rTMS - iTBS Device: rTMS - cTBS Early Phase 1

Detailed Description:
  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.
  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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jyoti Mishra, PhD 8588220568 braine@ucsd.edu

Locations
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United States, California
Altman Clinical & Translational Research Institute Recruiting
La Jolla, California, United States, 92037
Contact: Jyoti Mishra, PhD    858-822-0568    jymishra@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jyoti Mishra, PhD University of California, San Diego

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Responsible Party: Jyoti Mishra, Asst Professor IR, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03946059     History of Changes
Other Study ID Numbers: BrainE_TMS
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes