Tolerability, Safety and Efficacy of the HAC-Coil Deep Transcranial Magnetic Stimulation in Medication Resistance Obsessive Compulsive Disorder (OCD) Subjects

Study Overview
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Brief Summary
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The purpose of this study is to test whether the combination of deep transcranial magnetic stimulation (DTMS) treatment with customary medication for obsessive compulsive disorder (OCD) patients is effective than treatment that include only medication.

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Device: Deep TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Men and Women 18-65 years of age. Diagnosed as suffering from OCD according to DSM-IV. Patients having OCD of at least moderate severity (YBOCS score of 20 or above). Patients are maintained on an medication at steady dosages for at least 8 weeks before study entry and for the duration of the trail. Negative answers on safety screening questionnaire for transcranial magnetic stimulation. According to the treating physician the patients is compliant with taking medication. Capable and willing to provide informed consent. Able to adhere to treatment schedule. Patients that participate in behavioral therapy, will be in the maintaining stage and not in the active or intensive stage. Exclusion Criteria: Any other Axis I diagnosis as the primary diagnosis. History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first degree relatives). OCD patients that have only symptoms of hoarders) patients with Suicidal tendencies, or the patients is diagnosed as having a Suicidal tendencies by the treating physician. 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. History of head injury necessitating cranial surgery or prolonged coma. History of any metal in the head including the eyes and ears (outside the mouth). Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps. History of frequent or severe headaches. History of migraine. History of significant hearing loss. Individuals with a 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 History of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine). Inadequate communication with the patient. Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study. Participants who suffer from an unstable physical, systemic and metabolic disorders such as instabilized blood pressure or acute, unstable cardiac disease. Women who are breast-feeding. Known or suspected pregnancy. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: healthy volunteeres<br>this arm will undergo only EEG measurement | |
| Active Comparator: real - low frequency<br>this arm will receive DTMS treatment with low frequency | Device: Deep TMS<br>* deep transcranial magnetic stimulation<br>|
| Active Comparator: real - high frequency<br>this arm will receive DTMS treatment with high frequency | Device: Deep TMS<br>* deep transcranial magnetic stimulation<br>|
| Sham Comparator: sham - low / high frequency<br>this arm will receive DTMS sham treatment with low or high frequency | Device: Deep TMS<br>* deep transcranial magnetic stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder) |  | the primary outcome will be measure at day, 8, 22, 31, and 33 |