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

Primary Purpose

Obsessive Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Deep TMS
Sponsored by
Brainsway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Sham Comparator

Arm Label

healthy volunteeres

real - low frequency

real - high frequency

sham - low / high frequency

Arm Description

this arm will undergo only EEG measurement

this arm will receive DTMS treatment with low frequency

this arm will receive DTMS treatment with high frequency

this arm will receive DTMS sham treatment with low or high frequency

Outcomes

Primary Outcome Measures

Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder)

Secondary Outcome Measures

Full Information

First Posted
April 11, 2011
Last Updated
July 13, 2020
Sponsor
Brainsway
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1. Study Identification

Unique Protocol Identification Number
NCT01343732
Brief Title
Tolerability, Safety and Efficacy of the HAC-Coil Deep Transcranial Magnetic Stimulation in Medication Resistance Obsessive Compulsive Disorder (OCD) Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainsway

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteeres
Arm Type
No Intervention
Arm Description
this arm will undergo only EEG measurement
Arm Title
real - low frequency
Arm Type
Active Comparator
Arm Description
this arm will receive DTMS treatment with low frequency
Arm Title
real - high frequency
Arm Type
Active Comparator
Arm Description
this arm will receive DTMS treatment with high frequency
Arm Title
sham - low / high frequency
Arm Type
Sham Comparator
Arm Description
this arm will receive DTMS sham treatment with low or high frequency
Intervention Type
Device
Intervention Name(s)
Deep TMS
Intervention Description
deep transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder)
Time Frame
the primary outcome will be measure at day, 8, 22, 31, and 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients Men and Women 18-65 years of age. Diagnosed as suffering from OCD according to DSM-IV. Patients having OCD of at least moderate severity (YBOCS score of 20 or above). Patients are maintained on an medication at steady dosages for at least 8 weeks before study entry and for the duration of the trail. Negative answers on safety screening questionnaire for transcranial magnetic stimulation. According to the treating physician the patients is compliant with taking medication. Capable and willing to provide informed consent. Able to adhere to treatment schedule. Patients that participate in behavioral therapy, will be in the maintaining stage and not in the active or intensive stage. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yossef Zohar, Prof.
Phone
9723-5303300
Email
joseph.zohar@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yossef Zohar, Prof.
Organizational Affiliation
Sheba Medical Center, ramat-gan, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yossef Zohar, Prof.
Phone
9723-5303300
Email
joseph.zohar@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yossef Zohar, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28927961
Citation
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.
Results Reference
derived

Learn more about this trial

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

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