TMS Modulation of Insula-related Brain Networks (TMS_INS)

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: Healthy Subjects
• Intervention / Treatment: Device: repeated transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label; Participants will undergo 5 sessions of active rTMS	Device: repeated transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in functional connectivity strength measured with functional magnetic resonance imaging	baseline and 1 week

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): November 4, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pro00069059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO