Obsessive Compulsive DisorderNCT01343732
Tolerability, Safety and Efficacy of the HAC-Coil Deep Transcranial Magnetic Stimulation in Medication Resistance Obsessive Compulsive Disorder (OCD) Subjects
A study testing Deep TMS in people with Obsessive Compulsive Disorder, run by Brainsway at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Yossef Zohar, Prof., 9723-5303300, joseph.zohar@sheba.health.gov.il
Yossef Zohar, Prof.
About this study
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
- Being tested
- Deep TMS
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep TMSDevice
deep transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Deep TMS |
| real - high frequency | Active comparator | this arm will receive DTMS treatment with high frequency Receives: Device: Deep TMS |
| sham - low / high frequency | Sham comparator | this arm will receive DTMS sham treatment with low or high frequency Receives: Device: Deep TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder)
Measured: the primary outcome will be measure at day, 8, 22, 31, and 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yossef Zohar, Prof., Principal investigator, Sheba Medical Center, ramat-gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343732
- Sponsor's protocol ID
- OCD-DTMS-1
- Status last verified
- Jan 2020
- First submitted
- 11 Apr 2011
- Last updated
- 14 Jul 2020
- Results posted
- No
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.
PubMed 28927961
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability, Safety and Efficacy of the HAC-Coil Deep Transcranial Magnetic Stimulation in Medication Resistance Obsessive Compulsive Disorder (OCD) Subjects
- ClinicalTrials.gov ID
- NCT01343732
- Acronym / sponsor ID
- OCD-DTMS-1
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy volunteeres | No intervention | –this arm will undergo only EEG measurement |
| real - low frequency | Active comparator | Device: Deep TMSthis arm will receive DTMS treatment with low frequency |
| real - high frequency | Active comparator | Device: Deep TMSthis arm will receive DTMS treatment with high frequency |
| sham - low / high frequency | Sham comparator | Device: Deep TMSthis arm will receive DTMS sham treatment with low or high frequency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep TMSdeep transcranial magnetic stimulation | Device | real - high frequency, real - low frequency, sham - low / high frequency |
Primary outcome
Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder)
Time frame: the primary outcome will be measure at day, 8, 22, 31, and 33
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 28927961Carmi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yossef Zohar, Prof. principal investigator
Sheba Medical Center, ramat-gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep TMS in people with Obsessive Compulsive Disorder, run by Brainsway at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yossef Zohar, Prof. (9723-5303300, joseph.zohar@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y-BOCS Scale (Yale-Brown Obsessive Compulsive Disorder) (time frame: the primary outcome will be measure at day, 8, 22, 31, and 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.