TMS Modulation of Insula-related Brain Networks

Healthy Subjects Clinical Trial

— TMS_INS  

Official title:

TMS Modulation of Insula-related Brain Networks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689323
• Other study ID #: Pro00069059
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: June 19, 2017
• Start date: March 2016
• Est. completion date: November 4, 2016

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 4, 2016
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• repeated transcranial magnetic stimulation

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional connectivity strength measured with functional magnetic resonance imaging		baseline and 1 week