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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Brainsway.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343732
First Posted: April 28, 2011
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brainsway
  Purpose
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.

Condition Intervention
Obsessive Compulsive Disorder Device: Deep TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Brainsway:

Primary Outcome Measures:
  • Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder) [ Time Frame: the primary outcome will be measure at day, 8, 22, 31, and 33 ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: healthy volunteeres
this arm will undergo only EEG measurement
Active Comparator: real - low frequency
this arm will receive DTMS treatment with low frequency
Device: Deep TMS
deep transcranial magnetic stimulation
Active Comparator: real - high frequency
this arm will receive DTMS treatment with high frequency
Device: Deep TMS
deep transcranial magnetic stimulation
Sham Comparator: sham - low / high frequency
this arm will receive DTMS sham treatment with low or high frequency
Device: Deep TMS
deep transcranial magnetic stimulation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 before study entry and for the duration of the trail.
  6. Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
  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 and not in the active or intensive stage.

Exclusion Criteria:

  1. Any other Axis I diagnosis as the primary diagnosis.
  2. History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history 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 Suicidal tendencies by the treating physician.
  5. 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.
  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 any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
  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 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

  13. History of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
  14. Inadequate communication with the patient.
  15. Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
  16. Participants who suffer from an unstable physical, systemic and metabolic disorders such 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 of contraception when engaging in sexual intercourse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343732


Contacts
Contact: yossef Zohar, Prof. 9723-5303300 joseph.zohar@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Yossef Zohar, Prof.    9723-5303300    joseph.zohar@sheba.health.gov.il   
Principal Investigator: Yossef Zohar, Prof.         
Sponsors and Collaborators
Brainsway
Investigators
Principal Investigator: Yossef Zohar, Prof. Sheba Medical Center, ramat-gan, Israel
  More Information

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01343732     History of Changes
Other Study ID Numbers: OCD-DTMS-1
First Submitted: April 11, 2011
First Posted: April 28, 2011
Last Update Posted: January 27, 2015
Last Verified: April 2011

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders


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