Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation

NCT03687892 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-11-09

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Summary

The investigators plan to use functional magnetic resonance imaging (fMRI) methods to assess brain changes following spaced theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (rTMS), in 10 healthy participants. The investigators will measure the effects of both excitatory (intermittent, iTBS) and inhibitory (continuous, cTBS) TBS applied to the motor cortex, a system that when stimulated produces a readily observable behavioral response (e.g., movement of a given body regions). In addition to brain activity, we will assess the effects of TBS on motor responses and pain perception. The goal is to determine how brain activity and blood flow during tasks and at rest change following the applications of spaced cTBS and iTBS. Additionally, the aim is to determine the duration of the spaced TBS effects on brain activity and behavior. This study will provide an understanding of the functional brain and behavioral changes that occur following spaced TBS to the motor cortex and has implications for reducing the long treatment schedules associated with classical rTMS protocols.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

continuous Theta Burst Stimulation

Continuous Theta Burst Simulation will be applied in a continuous manner resulting in cortical excitability.

DEVICE

intermittent Theta Burst Stimulation

Intermittent Theta Burst Stimulation will be applied in an intermittent manner resulting in cortical inhibition.

Sponsors & Collaborators

Principal Investigators

  • Nolan Williams, M.D. · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-10-22
Completion
2022-10-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687892 on ClinicalTrials.gov