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

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.

Study Overview

• Status: Unknown
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Device: Deep TMS

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yossef Zohar, Prof.; Phone Number: 9723-5303300; Email: joseph.zohar@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Yossef Zohar, Prof.; Phone Number: 9723-5303300; Email: joseph.zohar@sheba.health.gov.il
    • Principal Investigator: Yossef Zohar, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brainsway
• Investigators: Principal Investigator: Yossef Zohar, Prof., Sheba Medical Center, ramat-gan, Israel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: OCD-DTMS-1