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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919423
Recruitment Status : Completed
First Posted : September 29, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: transcranial magnetic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: TMS Modulation of Insula-related Brain Networks.02
Study Start Date : December 2016
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919423


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Merideth Addicott, PhD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol and Statistical Analysis Plan  [PDF] October 21, 2016

More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02919423    
Other Study ID Numbers: Pro00077293
First Posted: September 29, 2016    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No