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

Butler Hospital

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: rTMS; Device: sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04165577

1901-003

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 7 patient groups

OCD, Active TMS

Experimental group

Description:

Participants with OCD who receive active rTMS

Treatment:

Device: rTMS

OCD, Sham TMS

Sham Comparator group

Description:

Participants with OCD who receive sham rTMS

Treatment:

Device: sham rTMS

Healthy Control, Active TMS

Other group

Description:

Healthy control participants who receive active rTMS

Treatment:

Device: rTMS

Healthy Control, Sham TMS

Other group

Description:

Healthy control participants who receive sham rTMS

Treatment:

Device: sham rTMS

Healthy Control, Active TMS (1 session)

Other group

Description:

Healthy control participants who receive 1 session of active, open-label rTMS

Treatment:

Device: rTMS

Healthy Control, Active TMS (3 sessions)

Other group

Description:

Healthy control participants who receive 3 sessions of active, open-label rTMS

Treatment:

Device: rTMS

OCD, Active TMS (3 session)

Other group

Description:

Participants with OCD who receive 3 sessions of active, open-label rTMS

Treatment:

Device: rTMS