TMS Modulation of Insula-related Brain Networks.02 (TMSINS02)

January 23, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 Hz TMS
active TMS will be administered
Device: transcranial magnetic stimulation
Active Comparator: 1 Hz TMS
active TMS will be administered
Device: transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Merideth Addicott, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

January 25, 2018

Study Completion (Actual)

January 25, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00077293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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