Obsessive-Compulsive Disorder (OCD)NCT07896837
Continuous Theta-Burst Stimulation for Obsessive-Compulsive Disorder: An Open-Label Study
A study testing Continuous Theta-Burst Stimulation in people with Obsessive-Compulsive Disorder (OCD) and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
This single-arm, open-label study evaluates short-term symptom improvement and tolerability of continuous theta-burst stimulation (cTBS), a non-invasive brain stimulation technique, in adults with obsessive-compulsive disorder seeking a non-drug treatment option. Participants receive cTBS for 15 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD), Transcranial Magnetic Stimulation, Electroencephalography
- What is being tested?
- Continuous Theta-Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2019to 31 Aug 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) age of 18-60 years; (2) OCD diagnosis confirmed by at least two psychiatrists; (3) a total score of ≥ 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) or ≥ 10 for obsessions/compulsions only; and (4) medication-naïve status or a stable medication regimen followed for at least 2 weeks.
Who cannot join
- (1) comorbid psychiatric disorders other than OCD; (2) severe physical or neurological disorders; (3) significant suicidal ideation; (4) receipt of neuromodulation treatments, such as TMS, transcranial direct current stimulation, or electroconvulsive therapy (ECT) within the past 6 months; and (5) a Hamilton Anxiety Rating Scale (HAMA) score of > 14 or a Hamilton Depression Rating Scale (HAMD) score of > 17.
Trial locations and contacts
1 site in 1 country.
About this study
This single-arm, open-label study evaluates short-term symptom improvement and tolerability of continuous theta-burst stimulation (cTBS), a non-invasive brain stimulation technique, in adults with obsessive-compulsive disorder seeking a non-drug treatment option. Participants receive cTBS for 15 consecutive days. Symptoms are assessed before treatment and 1-2 days after the treatment course.
Read the detailed description
This study uses a single-arm, open-label design to evaluate short-term clinical changes following cTBS in adults with OCD seeking a non-pharmacological intervention. All enrolled participants receive active cTBS, with no sham or other treatment comparison group. The study focuses on within-participant changes from baseline to the post-treatment assessment.
Stimulation targets the individually localized right pre-supplementary motor area (pre-SMA). Pretreatment structural and resting-state functional magnetic resonance imaging are used for individualized targeting. The stimulation site is selected within the right pre-SMA based on its functional connectivity with the right subthalamic nucleus. Neuronavigation guides coil placement during treatment.
Participants receive three cTBS stimulation blocks per day, totaling 1,800 pulses daily, over 15 consecutive days. Stimulation intensity is set at 80% of the resting motor threshold. The short duration of each stimulation block motivates investigation of this approach in clinical practice; overall visit duration also includes targeting, preparation, and intervals between stimulation blocks.
The primary outcome is the change in Y-BOCS total score from pretreatment to 1-2 days after completion of the treatment course. Anxiety and depressive symptoms are assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale, respectively.
Treatment tolerability is assessed by asking participants about discomfort and other adverse experiences during treatment sessions and after completion of the course. No dedicated adverse-event rating scale is used. Clinical outcomes are interpreted in the context of the open-label, uncontrolled design.
- Conditions
- Obsessive-Compulsive Disorder (OCD), Transcranial Magnetic Stimulation, Electroencephalography
- Being tested
- Continuous Theta-Burst 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.
Continuous Theta-Burst StimulationDevice
Continuous theta-burst stimulation (cTBS) is delivered to the individually localized right pre-supplementary motor area (pre-SMA) using a Magstim Rapid2 stimulator with a 70-mm figure-of-eight coil. The target is selected based on pretreatment resting-state fMRI connectivity with the right subthalamic nucleus, and coil placement is guided by neuronavigation. Stimulation consists of three-pulse bursts at 50 Hz repeated at 5 Hz, at 80% of the resting motor threshold. Three sessions of 600 pulses each are delivered daily at 15-minute intersession intervals, totaling 1,800 pulses per day, for 15 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active cTBS | Experimental | Not described Receives: Device: Continuous Theta-Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.
Measured: pre-treatment; 1-2 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start22 Aug 2019
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Zhu, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896837
- Sponsor's protocol ID
- OCD-cTBS-01
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Theta-Burst Stimulation for Obsessive-Compulsive Disorder: An Open-Label Study
- ClinicalTrials.gov ID
- NCT07896837
- Acronym / sponsor ID
- OCD-cTBS-01
- Conditions
- Obsessive-Compulsive Disorder (OCD), Transcranial Magnetic Stimulation, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 27 Oct 2026 (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 single-arm, open-label study evaluates short-term symptom improvement and tolerability of continuous theta-burst stimulation (cTBS), a non-invasive brain stimulation technique, in adults with obsessive-compulsive disorder seeking a non-drug treatment option. Participants receive cTBS for 15 consecutive days. Symptoms are assessed before treatment and 1-2 days after the treatment course.
Detailed description
This study uses a single-arm, open-label design to evaluate short-term clinical changes following cTBS in adults with OCD seeking a non-pharmacological intervention. All enrolled participants receive active cTBS, with no sham or other treatment comparison group. The study focuses on within-participant changes from baseline to the post-treatment assessment.
Stimulation targets the individually localized right pre-supplementary motor area (pre-SMA). Pretreatment structural and resting-state functional magnetic resonance imaging are used for individualized targeting. The stimulation site is selected within the right pre-SMA based on its functional connectivity with the right subthalamic nucleus. Neuronavigation guides coil placement during treatment.
Participants receive three cTBS stimulation blocks per day, totaling 1,800 pulses daily, over 15 consecutive days. Stimulation intensity is set at 80% of the resting motor threshold. The short duration of each stimulation block motivates investigation of this approach in clinical practice; overall visit duration also includes targeting, preparation, and intervals between stimulation blocks.
The primary outcome is the change in Y-BOCS total score from pretreatment to 1-2 days after completion of the treatment course. Anxiety and depressive symptoms are assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale, respectively.
Treatment tolerability is assessed by asking participants about discomfort and other adverse experiences during treatment sessions and after completion of the course. No dedicated adverse-event rating scale is used. Clinical outcomes are interpreted in the context of the open-label, uncontrolled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active cTBS | Experimental | Device: Continuous Theta-Burst Stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) age of 18-60 years; (2) OCD diagnosis confirmed by at least two psychiatrists; (3) a total score of ≥ 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) or ≥ 10 for obsessions/compulsions only; and (4) medication-naïve status or a stable medication regimen followed for at least 2 weeks.
Key exclusion criteria (1 listed)
- (1) comorbid psychiatric disorders other than OCD; (2) severe physical or neurological disorders; (3) significant suicidal ideation; (4) receipt of neuromodulation treatments, such as TMS, transcranial direct current stimulation, or electroconvulsive therapy (ECT) within the past 6 months; and (5) a Hamilton Anxiety Rating Scale (HAMA) score of > 14 or a Hamilton Depression Rating Scale (HAMD) score of > 17.
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 |
|---|---|---|
| Continuous Theta-Burst StimulationContinuous theta-burst stimulation (cTBS) is delivered to the individually localized right pre-supplementary motor area (pre-SMA) using a Magstim Rapid2 stimulator with a 70-mm figure-of-eight coil. The target is selected based on pretreatment resting-state fMRI connectivity with the right subthalamic nucleus, and coil placement is guided by neuronavigation. Stimulation consists of three-pulse bursts at 50 Hz repeated at 5 Hz, at 80% of the resting motor threshold. Three sessions of 600 pulses each are delivered daily at 15-minute intersession intervals, totaling 1,800 pulses per day, for 15 consecutive days. | Device | Active cTBS |
Primary outcome
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Time frame: pre-treatment; 1-2 days post-treatment
The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Theta-Burst Stimulation in people with Obsessive-Compulsive Disorder (OCD) and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Oct 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (time frame: pre-treatment; 1-2 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.