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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02689323
Other study ID # Pro00069059
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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