Obsessive-Compulsive DisorderNCT07116785
Accelerated Rotational Field Deep TMS for Treating OCD
A study testing BrainsWay Deep TMS HAC/H7-Coil in people with Obsessive-Compulsive Disorder, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- BrainsWay Deep TMS HAC/H7-Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Sep 2023to 14 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- Diagnosed as suffering from OCD according to the DSM-V.
- Subjects with a YBOCS score of >20.
- If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
- If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
- Have negative or justified responses by the investigator to all questions listed on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
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- According to the treating physician the subject is compliant with taking medication, if applicable.
- Subject is capable and willing to provide informed consent and assent.
- Willing and able to adhere to the treatment schedule.
- All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.
Who cannot join
- Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- 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 ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
- Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
- History of significant hearing loss.
- Subjects with significant neurological disorder or insult
- Substance use disorder within the past 6 months (except nicotine and caffeine and based on the doctor's judgment).
- Currently participating in another therapeutic clinical study.
- Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
- Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
- Significant possibility of death within eighteen months of baseline.
- Planned surgeries that will interrupt the study schedule within four months of baseline.
- Women who are breast-feeding.
- Women who are pregnant or with 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. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 8410101
Dor Shukrun, PhD Student, +972 547551542, dor.yshukrun@gmail.com
About this study
Official title: A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of Accelerated BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) Protocol in Obsessive-Compulsive Subjects
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Read the detailed description
This study is a randomized, double-blind clinical trial designed to compare the efficacy of active rfTMS coil targeting the mPFC and ACC with an inactive sham treatment. Conducted over a 13-week period, the trial includes 39 treatment sessions following an accelerated protocol. Eligible participants are randomly assigned in a 1:1 ratio to either the active treatment or sham group. Each daily treatment comprises three sessions separated by 1-hour intervals, resulting in a total treatment duration of 2.5 hours per day. The treatment regimen is structured into three distinct phases (Figure 1): (1) an acute phase (week 1), in which participants are treated for five consecutive days (totaling 15 sessions); (2) a maintenance phase (weeks 2-6), during which participants are treated once per week for five weeks (totaling 15 sessions); and (3) a follow-up phase during which participants are treated every visit at weeks 8, 10, and 13 (totaling 9 sessions). Imaging sessions are conducted at baseline and at the end of the maintenance session.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- BrainsWay Deep TMS HAC/H7-Coil, BrainsWay Deep TMS Sham Coil
- Keywords
- Deep TMS, Rotational Field
- 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.
BrainsWay Deep TMS HAC/H7-CoilDevice
Rotational field TMS (rfTMS) is a novel technology where two orthogonal coils are operated with a 90 phase shift between them. The combined electric field vector of rfTMS from both coils rotates up to a complete cycle during the TMS pulse. This method overcomes the inherent limitation of conventional unidirectional TMS by influencing neurons in various orientations (Roth et al., 2020b). This unique advance bears enormous potential for therapeutic applications in various neuropsychiatric disorders. The coil Array includes the H7 coil as the lower coil, and an upper coil perpendicular to it. Hence, the HAC/H7 coil Array induces similar electric field distribution and affects the same brain structures as the H7 coil, but stimulates neurons in various orientations within these regions.
BrainsWay Deep TMS Sham CoilDevice
Participants assigned to this intervention will receive sham stimulation using a BrainsWay Deep TMS sham coil that mimics the sensation and acoustic properties of active stimulation but does not deliver effective magnetic pulses to the brain. This condition is used as a placebo control to blind participants and investigators.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Experimental | Not described Receives: Device: BrainsWay Deep TMS HAC/H7-Coil |
| Sham TMS | Sham comparator | Not described Receives: Device: BrainsWay Deep TMS Sham Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale (YBOCS)
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups.
Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
Measured: 6 weeks
Secondary outcomes (1)
Yale Brown Obsessive Compulsive Scale (YBOCS)
Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start19 Sep 2023
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Dec 2028 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel assignment, randomized controlled trial comparing the effects of accelerated rotational-field deep transcranial magnetic stimulation versus sham stimulation in patients with OCD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway
- Responsible party
- Principal investigator, Dor Shukrun, Ben-Gurion University of the Negev
- Investigators
- Abraham Zangen, Prof., Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116785
- Sponsor's protocol ID
- 0140-22-SOR
- Other IDs
- 0140-22-SOR
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shukrun D, Shalev H, Gulevsky T, Harel M, Zangen A. Distinct structural abnormalities in obsessive-compulsive and alcohol use disorders. Eur Arch Psychiatry Clin Neurosci. 2026 Sep 19. doi: 10.1007/s00406-026-02375-y. Online ahead of print.
PubMed 42762239
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of Accelerated BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) Protocol in Obsessive-Compulsive Subjects
- ClinicalTrials.gov ID
- NCT07116785
- Acronym / sponsor ID
- 0140-22-SOR
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Deep TMS, Rotational Field
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Brainsway
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Dec 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- 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.
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Detailed description
This study is a randomized, double-blind clinical trial designed to compare the efficacy of active rfTMS coil targeting the mPFC and ACC with an inactive sham treatment. Conducted over a 13-week period, the trial includes 39 treatment sessions following an accelerated protocol. Eligible participants are randomly assigned in a 1:1 ratio to either the active treatment or sham group. Each daily treatment comprises three sessions separated by 1-hour intervals, resulting in a total treatment duration of 2.5 hours per day. The treatment regimen is structured into three distinct phases (Figure 1): (1) an acute phase (week 1), in which participants are treated for five consecutive days (totaling 15 sessions); (2) a maintenance phase (weeks 2-6), during which participants are treated once per week for five weeks (totaling 15 sessions); and (3) a follow-up phase during which participants are treated every visit at weeks 8, 10, and 13 (totaling 9 sessions). Imaging sessions are conducted at baseline and at the end of the maintenance session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel assignment, randomized controlled trial comparing the effects of accelerated rotational-field deep transcranial magnetic stimulation versus sham stimulation in patients with OCD
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Experimental | Device: BrainsWay Deep TMS HAC/H7-Coil |
| Sham TMS | Sham comparator | Device: BrainsWay Deep TMS Sham Coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Outpatients
- Diagnosed as suffering from OCD according to the DSM-V.
- Subjects with a YBOCS score of >20.
- If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
- If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
Key exclusion criteria (19 listed)
- Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- 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 |
|---|---|---|
| BrainsWay Deep TMS HAC/H7-CoilRotational field TMS (rfTMS) is a novel technology where two orthogonal coils are operated with a 90 phase shift between them. The combined electric field vector of rfTMS from both coils rotates up to a complete cycle during the TMS pulse. This method overcomes the inherent limitation of conventional unidirectional TMS by influencing neurons in various orientations (Roth et al., 2020b). This unique advance bears enormous potential for therapeutic applications in various neuropsychiatric disorders. The coil Array includes the H7 coil as the lower coil, and an upper coil perpendicular to it. Hence, the HAC/H7 coil Array induces similar electric field distribution and affects the same brain structures as the H7 coil, but stimulates neurons in various orientations within these regions. | Device | Active TMS |
| BrainsWay Deep TMS Sham CoilParticipants assigned to this intervention will receive sham stimulation using a BrainsWay Deep TMS sham coil that mimics the sensation and acoustic properties of active stimulation but does not deliver effective magnetic pulses to the brain. This condition is used as a placebo control to blind participants and investigators. | Device | Sham TMS |
Primary outcome
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: 6 weeks
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
1 secondary outcome
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 42762239Shukrun D, Shalev H, Gulevsky T, Harel M, Zangen A. Distinct structural abnormalities in obsessive-compulsive and alcohol use disorders. Eur Arch Psychiatry Clin Neurosci. 2026 Sep 19. doi: 10.1007/s00406-026-02375-y. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Abraham Zangen, Prof. principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainsWay Deep TMS HAC/H7-Coil in people with Obsessive-Compulsive Disorder, run by Ben-Gurion University of the Negev 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 19 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dor Shukrun, PhD Student (+972547551542, dor.yshukrun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (YBOCS) (time frame: 6 weeks). 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 NCT07116785, 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 12 Aug 2025.