Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT02355002
Eligibility Criteria:
Inclusion Criteria:
1. 18-65 years of age.
2. Proficient in English.
3. A diagnosis of primary OCD (as determined by SCID).
4. Yale-Brown Obsessive Compulsive Scale total score ≥ 16.
5. Normal (or corrected) vision.
6. Stable medication regimen or medication free for ≥ 12 weeks prior to study; benzodiazepine free ≥ 2 weeks.
7. Right-handed (Edinburgh Handedness Inventory - Short Form total score ≥ 61)
8. Able to give informed consent.
Exclusion Criteria:
1. Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
2. Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
3. Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference.
4. Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen).
5. Use of Tricyclic Antidepressants (e.g. Clomipramine).
6. Use of other psychotropic medications (e.g., SSRIs) will be allowed provided the dose has been stable for \> 12 weeks.
7. Documented resistance to 4 or more valid pharmacological trials of 2 or more different medication classes (e.g. SSRIs and TCAs).
8. Previous exposure to TMS.
9. Major/chronic medical conditions.
10. History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
11. Prior neurosurgical procedure.
12. Metal in the body, metal injury to the eyes.
13. History of seizures.
14. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
15. Pregnancy; breastfeeding or nursing; for women of childbearing a pregnancy test (to be ruled out by urine β-HCG) will be conducted prior to study.
16. Currently in Cognitive Behavioral Therapy (CBT).
17. Diagnosis of primary sleep disorder such as primary insomnia, narcolepsy, sleep apnea, shift work sleep disorder and others. Sleep disorders such as insomnia or hypersomnia that are secondary to depression or OCD are permitted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02355002
Study Brief:
Protocol Section:
NCT02355002