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TMS Modulation of Insula-related Brain Networks.02 (TMSINS02)

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Duke University

Status

Completed

Conditions

Healthy Subjects

Treatments

Device: transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02919423
Pro00077293

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

36 participants in 2 patient groups

10 Hz TMS
Active Comparator group
Description:
active TMS will be administered
Treatment:
Device: transcranial magnetic stimulation
1 Hz TMS
Active Comparator group
Description:
active TMS will be administered
Treatment:
Device: transcranial magnetic stimulation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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