Obsessive-Compulsive DisorderNCT07065669
Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation
A study testing Dorsal medial Prefrontal Cortex intermittent theta burst stimulation and cTBS to ROFC in people with Obsessive-Compulsive Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Dorsal medial Prefrontal Cortex intermittent theta burst stimulation and cTBS to ROFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Jul 2027
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- outpatients
- ages 13 - 17 years
- meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score > 16 (moderate to severe).
- stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.
- participants may continue to take medications and record daily usage throughout the study.
- capacity to provide informed assent and parent or legal guardian able to provide consent.
- ability to tolerate clinical study procedures.
- successfully complete the screening forms without any contraindications.
Who cannot join
- Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.
- Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).
- TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.
- Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).
- Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).
- Current and anticipated continued treatment with excluded medication (See prohibited list).
- Inability to complete the research protocol as determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94107
Starlette Khim, BA, 415-514-5743, ocdteenTMS@ucsf.edu
James T McCracken, MD
About this study
This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents.
The project's primary goal is to examine whether adolescents can complete 3 consecutive weeks of TMS administered 5 days per week, and to describe the type of and how common individual side effects with TMS occur in adolescents with OCD.
Read more
Participants will:
- visit the clinic every weekday for 3 weeks (15 days) to receive TMS treatments
- have a brain MRI scan before TMS treatments begins and after finishing all TMS
- complete questionnaires and report changes in behavior and physical symptoms
Read the detailed description
This study's primary goal is to examine whether treatment with two forms of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) show acceptable tolerability, safety, and preliminary signals of efficacy for adolescents with Obsessive Compulsive Disorder (OCD) that has not responded satisfactorily to 1st line treatments. While TMS is FDA-approved for OCD in adults, data on TMS in youth with OCD is limited. Results will inform on how suitable TMS treatment is for adolescents with OCD, and guide future, larger studies.
The study is considered a randomized, single blind, clinical trial.
The design of the study is a two-group parallel comparative study of two different TMS stimulation sites, the orbito-frontal cortex (OFC) and the dorsal medial prefrontal cortex (dmPFC).
Model description: both groups will receive active TMS treatment sessions in clinic every weekday for 3 consecutive weeks (15 days). During each TMS session, participants in both groups will receive 3 TMS stimulations separated by a rest period, for a total of 45 individual TMS treatments. Study participants will receive TMS to only their assigned stimulation site.
Number of arms: there are two treatment arms based on assigned treatment site, an OFC arm and a dmPFC arm.
Masking: an independent evaluator will be masked to treatment arm assignment and adverse events. All other study personnel will not be masked.
Allocation: participants will be randomly assigned to group according to a computer-generated assignment schedule.
Enrollment: total planned enrollment is 30 eligible participants who are randomized.
Arm Information:
Arm titles-- orbitofrontal cortex (OFC) and dorsal medial prefrontal cortex (dmPFC) Arm types: the dmPFC arm is considered the intervention arm; the OFC arm is considered the active comparator arm.
Interventions:
Intervention type: Device (both arms)
Intervention name(s):
OFC - continuous theta burst stimulation (cTBS) dmPFC - intermittent theta burst stimulation (iTBS)
Intervention description:
OFC - three stimulations per day of 1,800 pulses/stimulation cTBS for 15 days dmPFC - three stimulations per day of 1,800 pulses/session iTBS for 15 days
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Dorsal medial Prefrontal Cortex intermittent theta burst stimulation, cTBS to ROFC
- Keywords
- Adolescent, transcranial magnetic stimulation
- 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.
Dorsal medial Prefrontal Cortex intermittent theta burst stimulationDevice
iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD
cTBS to ROFCDevice
continuous theta burst stimulation (cTBS) 1,800 pulses per session
| Study group | Role | What they receive |
|---|---|---|
| Right Orbitofrontal TBS | Experimental | continuous theta burst stimulation Receives: Device: cTBS to ROFC |
| TBS of dorsal, medial prefrontal cortex | Active comparator | intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC Receives: Device: Dorsal medial Prefrontal Cortex intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
Proportion (percentage) of all participants who enter the study, undergo a minimum of one TMS treatment, and complete the protocol-specified 15 TMS visits
Measured: Baseline to completion of all protocol visits, up to 8 weeks
Adverse events
Frequency (percentage) of individual adverse events
Measured: Baseline to completion of all protocol visits up to 8 weeks
Secondary outcomes (2)
Combined efficacy
Change in independent assessor-rated CY-BOCS II total score
Measured: Baseline to completion of all protocol visits, up to 8 weeks
Site efficacy
Compare changes in blinded clinician CY-BOCS II total by TMS site (OFC vs dmPFC)
Measured: From screening to end of treatment (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Two arm, randomized assignment to two types of transcranial magnetic stimulation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Hearst Foundations
- Responsible party
- Sponsor
- Investigators
- James T McCracken, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065669
- Sponsor's protocol ID
- 24-41216
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD to be shared will include both primary endpoint data and secondary endpoint data.
Publications
Vicheva P, Osborne C, Krieg SM, Ahmadi R, Shotbolt P. Transcranial magnetic stimulation for obsessive-compulsive disorder and post-traumatic stress disorder: A comprehensive systematic review and analysis of therapeutic benefits, cortical targets, and psychopathophysiological mechanisms. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111147. doi: 10.1016/j.pnpbp.2024.111147. Epub 2024 Sep 16.
PubMed 39293504Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
PubMed 31109199
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07065669
- Acronym / sponsor ID
- 24-41216
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Adolescent, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Hearst Foundations
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Jul 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.
This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents.
The project's primary goal is to examine whether adolescents can complete 3 consecutive weeks of TMS administered 5 days per week, and to describe the type of and how common individual side effects with TMS occur in adolescents with OCD.
Participants will:
- visit the clinic every weekday for 3 weeks (15 days) to receive TMS treatments
- have a brain MRI scan before TMS treatments begins and after finishing all TMS
- complete questionnaires and report changes in behavior and physical symptoms
Detailed description
This study's primary goal is to examine whether treatment with two forms of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) show acceptable tolerability, safety, and preliminary signals of efficacy for adolescents with Obsessive Compulsive Disorder (OCD) that has not responded satisfactorily to 1st line treatments. While TMS is FDA-approved for OCD in adults, data on TMS in youth with OCD is limited. Results will inform on how suitable TMS treatment is for adolescents with OCD, and guide future, larger studies.
The study is considered a randomized, single blind, clinical trial.
The design of the study is a two-group parallel comparative study of two different TMS stimulation sites, the orbito-frontal cortex (OFC) and the dorsal medial prefrontal cortex (dmPFC).
Model description: both groups will receive active TMS treatment sessions in clinic every weekday for 3 consecutive weeks (15 days). During each TMS session, participants in both groups will receive 3 TMS stimulations separated by a rest period, for a total of 45 individual TMS treatments. Study participants will receive TMS to only their assigned stimulation site.
Number of arms: there are two treatment arms based on assigned treatment site, an OFC arm and a dmPFC arm.
Masking: an independent evaluator will be masked to treatment arm assignment and adverse events. All other study personnel will not be masked.
Allocation: participants will be randomly assigned to group according to a computer-generated assignment schedule.
Enrollment: total planned enrollment is 30 eligible participants who are randomized.
Arm Information:
Arm titles-- orbitofrontal cortex (OFC) and dorsal medial prefrontal cortex (dmPFC) Arm types: the dmPFC arm is considered the intervention arm; the OFC arm is considered the active comparator arm.
Interventions:
Intervention type: Device (both arms)
Intervention name(s):
OFC - continuous theta burst stimulation (cTBS) dmPFC - intermittent theta burst stimulation (iTBS)
Intervention description:
OFC - three stimulations per day of 1,800 pulses/stimulation cTBS for 15 days dmPFC - three stimulations per day of 1,800 pulses/session iTBS for 15 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, randomized assignment to two types of transcranial magnetic stimulation
| Arm | Type | Receives |
|---|---|---|
| Right Orbitofrontal TBS | Experimental | Device: cTBS to ROFCcontinuous theta burst stimulation |
| TBS of dorsal, medial prefrontal cortex | Active comparator | Device: Dorsal medial Prefrontal Cortex intermittent theta burst stimulationintermittent theta burst stimulation (iTBS) will be delivered to the dmPFC |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- outpatients
- ages 13 - 17 years
- meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score > 16 (moderate to severe).
- stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.
- participants may continue to take medications and record daily usage throughout the study.
Key exclusion criteria (7 listed)
- Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.
- Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).
- TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.
- Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).
- Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).
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 |
|---|---|---|
| Dorsal medial Prefrontal Cortex intermittent theta burst stimulationiTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD | Device | TBS of dorsal, medial prefrontal cortex |
| cTBS to ROFCcontinuous theta burst stimulation (cTBS) 1,800 pulses per session | Device | Right Orbitofrontal TBS |
Primary outcome
Completion rate
Time frame: Baseline to completion of all protocol visits, up to 8 weeks
Proportion (percentage) of all participants who enter the study, undergo a minimum of one TMS treatment, and complete the protocol-specified 15 TMS visits
Adverse events
Time frame: Baseline to completion of all protocol visits up to 8 weeks
Frequency (percentage) of individual adverse events
2 secondary outcomes
Combined efficacy
Time frame: Baseline to completion of all protocol visits, up to 8 weeks
Site efficacy
Time frame: From screening to end of treatment (Week 4)
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 8 Sep 2026.
- Background: PubMed 39293504Vicheva P, Osborne C, Krieg SM, Ahmadi R, Shotbolt P. Transcranial magnetic stimulation for obsessive-compulsive disorder and post-traumatic stress disorder: A comprehensive systematic review and analysis of therapeutic benefits, cortical targets, and psychopathophysiological mechanisms. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111147. doi: 10.1016/j.pnpbp.2024.111147. Epub 2024 Sep 16.
- Background: PubMed 31109199Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.
- Individual participant dataSharing planned: Yes. IPD to be shared will include both primary endpoint data and secondary endpoint data.
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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.
James T McCracken, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal medial Prefrontal Cortex intermittent theta burst stimulation and cTBS to ROFC in people with Obsessive-Compulsive Disorder, run by University of California, San Francisco at 1 site in United States.
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 8 inclusion and 7 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 8 Sep 2026. 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 United States. 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. 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 Starlette Khim, BA (415-514-5743, ocdteenTMS@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: Baseline to completion of all protocol visits, up to 8 weeks). The study lists 2 primary outcomes in all. 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 NCT07065669, which also lists 2 linked publications.
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 8 Sep 2026.