TMS Modulation of Insula-related Brain Networks.02

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Device: transcranial magnetic stimulation

• Registration Number: NCT02919423
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-29
• Study Start: 2016-12
• Primary Completion: 2018-01-25
• Study Completion: 2018-01-25
• Results First Submitted: 2018-11-28
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Results First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
10 Hz TMS	transcranial magnetic stimulation	active TMS will be administered
1 Hz TMS	transcranial magnetic stimulation	active TMS will be administered

Primary Outcome Measures

Name	Time	Method
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States