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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165577
• Other study ID #: 1901-003
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: December 2, 2022

Study information

• Verified date: December 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• rTMS
1-Hz rTMS targeting frontal pole
• sham rTMS
sham rTMS targeting frontal pole

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in regional activation in orbitofrontal cortex	Change in task-based regional activation (assessed via functional magnetic resonance imaging; fMRI) in orbitofrontal cortex	Before rTMS and within 30 minutes immediately following rTMS
Other	Change in regional activation in dorsolateral prefrontal cortex	Change in task-based regional activation (assessed via fMRI) in dorsolateral prefrontal cortex	Before rTMS and within 30 minutes immediately following rTMS
Other	Change in regional activation in anterior cingulate cortex	Change in task-based regional activation (assessed via fMRI) in anterior cingulate cortex	Before rTMS and within 30 minutes immediately following rTMS
Other	Resting-state functional connectivity with ventral striatum	Resting-state functional connectivity with ventral striatum (assessed via fMRI)	Before rTMS and within 30 minutes immediately following rTMS
Other	Resting-state functional connectivity with dorsal striatum	Resting-state functional connectivity with dorsal striatum (assessed via fMRI)	Before rTMS and within 30 minutes immediately following rTMS
Other	Cognitive flexibility task performance	Behavioral performance on a cognitive flexibility task (% trials correct)	Before rTMS and within 30 minutes immediately following rTMS
Primary	Resting-state functional connectivity with ventral striatum	Resting-state functional connectivity with ventral striatum (assessed via fMRI)	Before rTMS and approximately 1 day following open-label rTMS
Primary	Resting-state functional connectivity with dorsal striatum	Resting-state functional connectivity with dorsal striatum (assessed via fMRI)	Before rTMS and approximately 1 day following open-label rTMS
Primary	Cognitive flexibility task performance	Behavioral performance on a cognitive flexibility task (% trials correct)	Before rTMS and approximately 1 day following open-label rTMS