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

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ClinicalTrials.gov Identifier: NCT01343732
Recruitment Status : Recruiting
First Posted : April 28, 2011
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

Brief 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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Device: Deep TMS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : June 2011
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01343732     History of Changes
Other Study ID Numbers: OCD-DTMS-1
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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