TMS Modulation of Insula-related Brain Networks

NCT02689323 | Completed

• 1 other identifier: Pro00069059
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Change in functional connectivity strength measured with functional magnetic resonance imaging

  baseline and 1 week

Study Arms (1)

Open label

EXPERIMENTAL

Participants will undergo 5 sessions of active rTMS

Device: repeated transcranial magnetic stimulation

Interventions

repeated transcranial magnetic stimulation DEVICE

Open label

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 23, 2016
• Study Start: March 1, 2016
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)