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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteeres | No Intervention | this arm will undergo only EEG measurement | |
| real - low frequency | Active Comparator | this arm will receive DTMS treatment with low frequency |
|
| real - high frequency | Active Comparator | this arm will receive DTMS treatment with high frequency |
|
| sham - low / high frequency | Sham Comparator | this arm will receive DTMS sham treatment with low or high frequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep TMS | Device | deep transcranial magnetic stimulation |
|
| 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 |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yossef Zohar, Prof. | Contact | 9723-5303300 | joseph.zohar@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Yossef Zohar, Prof. | Sheba Medical Center, ramat-gan, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28927961 | Derived | Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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