TMS Modulation of Insula-related Brain Networks

NCT ID: NCT02689323

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-04

Brief Summary

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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

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Open label

Participants will undergo 5 sessions of active rTMS

Group Type EXPERIMENTAL

repeated transcranial magnetic stimulation

Intervention Type DEVICE

Interventions

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repeated transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. generally healthy
2. between the ages of 18-55
3. right-handed

Exclusion Criteria

1. 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)
2. current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
3. meet DSM-5 criteria for current substance use disorder other than nicotine
4. use of psychoactive medications that would result in a positive urine drug screen
5. Current use of medications known to lower the seizure threshold
6. positive breath alcohol concentration
7. presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
8. among women, a positive urine pregnancy test
9. vision that cannot be corrected to 20/40
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00069059

Identifier Type: -

Identifier Source: org_study_id

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