TMS Modulation of Insula-related Brain Networks.02

NCT02919423 | Completed Results

• 1 other identifier: Pro00077293
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging

  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

Study Arms (2)

10 Hz TMS

ACTIVE COMPARATOR

active TMS will be administered

Device: transcranial magnetic stimulation

1 Hz TMS

ACTIVE COMPARATOR

active TMS will be administered

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

1 Hz TMS; 10 Hz TMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• generally healthy
• between the ages of 18-55
• right-handed

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Merideth Addicott, Assistant Professor
• Organization: University of Arkansas for Medical Sciences

maddicott@uams.edu

501-526-8436

Study Officials

• Merideth Addicott, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: December 1, 2016
• Primary Completion: January 25, 2018
• Study Completion: January 25, 2018
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)