Clinical trial NCT04165577: Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
Official title: Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Resting-state functional connectivity with ventral striatum
timeFrame: Before rTMS and approximately 1 day following open-label rTMS
measure: Resting-state functional connectivity with dorsal striatum
timeFrame: Before rTMS and approximately 1 day following open-label rTMS
measure: Cognitive flexibility task performance
timeFrame: Before rTMS and approximately 1 day following open-label rTMS
Secondary outcomes:
Other outcomes:
measure: Change in regional activation in orbitofrontal cortex
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
measure: Change in regional activation in dorsolateral prefrontal cortex
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
measure: Change in regional activation in anterior cingulate cortex
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
measure: Resting-state functional connectivity with ventral striatum
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
measure: Resting-state functional connectivity with dorsal striatum
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
measure: Cognitive flexibility task performance
timeFrame: Before rTMS and within 30 minutes immediately following rTMS
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Sarah Garnaat, PhD
role: PRINCIPAL_INVESTIGATOR
References: