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Effects of rTMS on Human Brain Activity

NCT04242810 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-01-10

No results posted yet for this study

Summary

The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI).

Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours.

MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.

Conditions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

DEVICE

rTMS

TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.

DEVICE

Sham rTMS

An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.

PROCEDURE

MRI scan

Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.

Sponsors & Collaborators

Principal Investigators

  • Robert Cabeza · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04242810 on ClinicalTrials.gov