TMS Modulation of Insula-related Brain Networks.02
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
10 Hz TMS
active TMS will be administered
Intervention: transcranial magnetic stimulation (Device)
1 Hz TMS
active TMS will be administered
Intervention: transcranial magnetic stimulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported