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Completed

NCT Number: NCT04165577

Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study

This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

OCD group

  • current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and
  • right-handed.

Inclusion criteria

Healthy Control group

  • 18-55 years of age;
  • ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
  • right-handed.

Exclusion criteria

OCD group

  • active problematic substance use;
  • lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature;
  • clinically significant hoarding symptoms;
  • active suicidal or homicidal ideation;
  • significant neurological disease or intracranial pathology;
  • use of medications which increase risk for seizures during TMS;
  • significant or unstable medical disorders or contraindication to TMS or MRI scan.

Exclusion criteria

Healthy Control group

  • current psychiatric diagnosis;
  • lifetime psychosis, bipolar mood disorder, or OCD;
  • active suicidal or homicidal ideation;
  • significant neurological disease or intracranial pathology;
  • use of psychiatric medications;
  • use of medications which increase risk for seizures during TMS;
  • significant or unstable medical disorders or contraindication to TMS or MRI scan.

Treatment and study plan

rTMS

Device

1-Hz rTMS targeting frontal pole

sham rTMS

Device

sham rTMS targeting frontal pole

Primary outcomes

  1. Resting-state functional connectivity with ventral striatum

    Time frame: Before rTMS and approximately 1 day following open-label rTMS

    Resting-state functional connectivity with ventral striatum (assessed via fMRI)

  2. Resting-state functional connectivity with dorsal striatum

    Time frame: Before rTMS and approximately 1 day following open-label rTMS

    Resting-state functional connectivity with dorsal striatum (assessed via fMRI)

  3. Cognitive flexibility task performance

    Time frame: Before rTMS and approximately 1 day following open-label rTMS

    Behavioral performance on a cognitive flexibility task (% trials correct)

Other outcomes

  1. Change in regional activation in orbitofrontal cortex

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Change in task-based regional activation (assessed via functional magnetic resonance imaging; fMRI) in orbitofrontal cortex

  2. Change in regional activation in dorsolateral prefrontal cortex

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Change in task-based regional activation (assessed via fMRI) in dorsolateral prefrontal cortex

  3. Change in regional activation in anterior cingulate cortex

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Change in task-based regional activation (assessed via fMRI) in anterior cingulate cortex

  4. Resting-state functional connectivity with ventral striatum

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Resting-state functional connectivity with ventral striatum (assessed via fMRI)

  5. Resting-state functional connectivity with dorsal striatum

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Resting-state functional connectivity with dorsal striatum (assessed via fMRI)

  6. Cognitive flexibility task performance

    Time frame: Before rTMS and within 30 minutes immediately following rTMS

    Behavioral performance on a cognitive flexibility task (% trials correct)

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2019
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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