Measuring Plasticity in SFC/dACC Following Theta-Burst-Stimulation Using TMS

NCT03946059 | Completed Results FDA Device

• 1 other identifier: BrainE_TMS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Cognitive Control

Outcome Measures

Primary Outcomes (1)

• Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation

  Change in superior frontal stimulus-evoked theta oscillations were measure on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The evoked EEG response (mid-frontal theta FCz as a source for superior frontal theta) was averaged across all cognitive tasks to yield a global cognitive task-averaged signal that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS.

  (Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart.

Secondary Outcomes (1)

• Post vs. Pre Change in Cognitive Performance

  (Post-Pre) iTBS and (Post-Pre) cTBS cognitive performance levels were measured one week apart.

Study Arms (2)

iTBS then cTBS

EXPERIMENTAL

Participants in this arm first receive the iTBS brain stimulation in week 1, then have a one-week washout period and then receive cTBS brain stimulation in week 2. 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. 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: iTBS then cTBS

cTBS then iTBS

EXPERIMENTAL

Participants in this arm first receive the cTBS brain stimulation in week 1, then have a one-week washout period and then receive iTBS brain stimulation in week 2.

Device: cTBS then iTBS

Interventions

iTBS then cTBS DEVICE

repetitive transcranial magnetic stimulation applied with intermittent theta-burst stimulation protocol applied in week 1 and continuous theta-burst stimulation protocol applied in week 2.

iTBS then cTBS

cTBS then iTBS DEVICE

repetitive transcranial magnetic stimulation applied with continuous theta-burst stimulation protocol applied in week 1 and intermittent theta-burst stimulation protocol applied in week 2.

cTBS then iTBS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adequate decisional capacity to make a choice about participating in this research study.

You may not qualify if:

• No major active neurologic/psychiatric disease
• No contraindications for rTMS
• No behavioral/medical factors that increase risk of seizure

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Altman Clinical & Translational Research Institute

La Jolla, California, 92037, United States

Location

Results Point of Contact

• Title: Dr. Jyoti Mishra
• Organization: University of California San Diego

jymishra@ucsd.edu

8582322855

Study Officials

• Jyoti Mishra, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will assess for each subject whether they have any guess, a priori, as to hypothesized effects of the iTBS vs. cTBS protocols (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 protocols. iTBS and cTBS protocols 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 treatment protocols.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor IR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: April 30, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-02

Locations

US (1)