Is There a New Gold Standard for the Treatment of Obsessive-Compulsive Disorder?
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Exposure and Response Prevention
Eligibility Criteria
Inclusion Criteria:
i. Outpatients ii. Men and women 18-70 years of age. iii. Patients diagnosed as suffering from OCD according to the BOCS and YBOCs. iv. Patients had an inadequate/intolerable response to SSRI, CBT (Exposure and Response Prevention) or both.
v. Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
vi. Patient is able to adhere to the treatment schedule.
Exclusion Criteria:
i. Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
ii. Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
iii. Patient has an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
iv. Patient has a history of head injury necessitating cranial surgery or prolonged coma.
v. Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
vi. Patient has a history of significant hearing loss. vii. Patients with significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Mini Mental State Exam score of less than or equal to 24 (for adult participants) viii. Patient has a history of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
ix. Inadequate communication with the patient. x. Patient is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
xi. Patients who suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure or acute, unstable cardiac disease.
xii. Women who are pregnant or with suspected pregnancy
Sites / Locations
- Envision Mind Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
H7 coil only
Cool D-B80 coil only
DTMS treatment using the H7 coil + ERP
rTMS treatment using the cool D-B80 coil + ERP
ERP only
patients undergoing DTMS treatment using the H7 coil
20 patients undergoing rTMS treatment using the cool D-B80 coil
20 patients undergoing DTMS treatment using the H7 coil + ERP
20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP
20 patients undergoing ERP only