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

NCT01343732 | Unknown

• 1 other identifier: OCD-DTMS-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

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

  the primary outcome will be measure at day, 8, 22, 31, and 33

Study Arms (4)

healthy volunteeres

NO INTERVENTION

this arm will undergo only EEG measurement

real - low frequency

ACTIVE COMPARATOR

this arm will receive DTMS treatment with low frequency

Device: Deep TMS

real - high frequency

ACTIVE COMPARATOR

this arm will receive DTMS treatment with high frequency

Device: Deep TMS

sham - low / high frequency

SHAM COMPARATOR

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

Device: Deep TMS

Interventions

Deep TMS DEVICE

deep transcranial magnetic stimulation

real - high frequency; real - low frequency; sham - low / high frequency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brainsway: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 28927961 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Yossef Zohar, Prof.

  Sheba Medical Center, ramat-gan, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yossef Zohar, Prof.

CONTACT

9723-5303300; joseph.zohar@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 28, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-01

Locations

IL (1)