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

NCT ID: NCT03946059

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2019-10-30

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).

Detailed 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.

Conditions

Cognitive Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

iTBS then cTBS

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.

Group Type: EXPERIMENTAL

iTBS then cTBS

Intervention Type: 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.

cTBS then iTBS

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.

Group Type: EXPERIMENTAL

cTBS then iTBS

Intervention Type: 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.

Interventions

iTBS then cTBS

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.

Intervention Type: DEVICE

cTBS then iTBS

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jyoti Mishra

Asst Professor IR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jyoti Mishra, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Altman Clinical & Translational Research Institute

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BrainE_TMS

Identifier Type: -

Identifier Source: org_study_id