TMS Modulation of Insula-related Brain Networks.02

The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

generally healthy
between the ages of 18-55
right-handed

Exclusion criteria

significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
meet DSM-5 criteria for current substance use disorder other than nicotine
use of psychoactive medications that would result in a positive urine drug screen
Current use of medications known to lower the seizure threshold
positive breath alcohol concentration
presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
among women, a positive urine pregnancy test
vision that cannot be corrected to 20/40

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Primary outcomes

Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging

Time frame: baseline and 1 week

Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: TMSINS02

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 29, 2016
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed