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

Last updated: July 13, 2020
Sponsor: Brainsway
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Panic Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT01343732
OCD-DTMS-1
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Outpatients

  2. Men and Women 18-65 years of age.

  3. Diagnosed as suffering from OCD according to DSM-IV.

  4. Patients having OCD of at least moderate severity (YBOCS score of 20 or above).

  5. Patients are maintained on an medication at steady dosages for at least 8 weeks beforestudy entry and for the duration of the trail.

  6. Negative answers on safety screening questionnaire for transcranial magneticstimulation.

  7. According to the treating physician the patients is compliant with taking medication.

  8. Capable and willing to provide informed consent.

  9. Able to adhere to treatment schedule.

  10. Patients that participate in behavioral therapy, will be in the maintaining stage andnot in the active or intensive stage.

Exclusion

Exclusion Criteria:

  1. Any other Axis I diagnosis as the primary diagnosis.

  2. History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) orhistory of such in first degree relatives).

  3. OCD patients that have only symptoms of hoarders)

  4. patients with Suicidal tendencies, or the patients is diagnosed as having a Suicidaltendencies by the treating physician.

  5. Increased risk of seizure for any reason, including prior diagnosis of increasedintracranial pressure, or history of significant head trauma with loss ofconsciousness for greater than or equal to 5 minutes.

  6. History of head injury necessitating cranial surgery or prolonged coma.

  7. History of any metal in the head including the eyes and ears (outside the mouth).

  8. Known history of any metallic particles in the eye, implanted cardiac pacemaker or anyintracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysmclips, shunts, stimulators, cochlear implants, or electrodes) or implanted medicalpumps.

  9. History of frequent or severe headaches.

  10. History of migraine.

  11. History of significant hearing loss.

  12. Individuals with a significant neurological disorder or insult including, but notlimited to: Any condition likely to be associated with increased intracranial pressure Spaceoccupying brain lesion History of cerebrovascular accident Transient ischemic attackwithin two years Cerebral aneurysm Dementia Parkinson's disease Huntington's choreaMultiple sclerosis

  13. History of substance abuse including alcoholism within the past 6 months (exceptnicotine and caffeine).

  14. Inadequate communication with the patient.

  15. Participation currently in another clinical study or enrolled in another clinicalstudy within 30 days prior to this study.

  16. Participants who suffer from an unstable physical, systemic and metabolic disorderssuch as instabilized blood pressure or acute, unstable cardiac disease.

  17. Women who are breast-feeding.

  18. Known or suspected pregnancy.

  19. Women of childbearing potential and not using a medically accepted form ofcontraception when engaging in sexual intercourse.

Study Design

Total Participants: 40
Study Start date:
June 01, 2011
Estimated Completion Date:
November 30, 2020

Connect with a study center

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

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