Obsessive - Compulsive DisorderNCT07480408
Neural Mechanisms of the Sensorymotor Circuit in Sensory Phenomena in OCD
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The goal of this clinical study is to investigate the neural mechanisms of abnormal sensory phenomena in patients with Obsessive-Compulsive Disorder and to evaluate whether modulation of the insula-supplementary motor area circuit can improve these symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- OCD with abnormal sensory phenomena
- Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Aged 18-55 years.
- Score ≥16 on the Yale-Brown Obsessive Compulsive Scale, indicating moderate to severe symptoms.
- Score >6 on the Sensory Phenomena Scale (SPS), indicating moderate to severe sensory phenomena.
- Right-handed.
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- Either medication-free or on stable medication for at least 8 weeks.
- OCD without abnormal sensory phenomena
- Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Aged 18-55 years.
- Score ≥16 on the Yale-Brown Obsessive Compulsive Scale.
- Score ≤6 on the Sensory Phenomena Scale (SPS).
- Right-handed.
- Either medication-free or on stable medication for at least 8 weeks.
Who cannot join
- Meeting diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for psychiatric disorders other than OCD or obsessive-compulsive personality disorder.
- OCD symptoms so severe that required assessments cannot be completed.
- Presence of severe suicidal ideation or high suicide risk.
- Pregnant women or women planning pregnancy in the near future.
- History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
- Contraindications to MRI, such as metallic implants.
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- Clinically significant medical illnesses or abnormal laboratory findings.
- Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.
- Healthy Controls Inclusion criteria
- No current or past psychiatric disorders meeting diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Aged 18-55 years.
- Right-handed. Exclusion criteria
- 1. Pregnant women or women planning pregnancy in the near future. 2. History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
- 3. Presence of severe suicidal ideation or high suicide risk. 4. Contraindications to MRI, such as metallic implants. 5. Clinically significant medical illnesses or abnormal laboratory findings. 6. Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai
Jiayue Cheng, Master, +8602134773503, chengjy_94@163.com
About this study
Official title: Neural Mechanisms of the Insula-Supplementary Motor Area Circuit in Sensory Phenomena in Obsessive-Compulsive Disorder
The goal of this clinical study is to investigate the neural mechanisms of abnormal sensory phenomena in patients with Obsessive-Compulsive Disorder and to evaluate whether modulation of the insula-supplementary motor area circuit can improve these symptoms. The study will include adult patients with OCD (with or without sensory phenomena) and healthy volunteers.
The main questions it aims to answer are:
Read more
- Do patients with OCD show abnormal activity in the insula-SMA circuit compared with healthy controls?
- Is this abnormality associated with the presence and severity of abnormal sensory phenomena?
- Can low-frequency rTMS targeting the Supplementary Motor Area improve sensory phenomena and obsessive-compulsive symptoms? Researchers will compare an on-line rTMS group (viewing body-focused videos during stimulation) with an off-line rTMS group (resting during stimulation) to evaluate whether task engagement enhances treatment effects.
Participants will:
- Complete clinical assessments and behavioral tasks.
- Undergo EEG and fMRI assessments.
- Receive low-frequency rTMS targeting the Supplementary Motor Area.
- Repeat assessments after the intervention.
Read the detailed description
Phase 1:
This part adopts a cross-sectional design. A total of 30 patients with Obsessive-Compulsive Disorder with sensory phenomena, 30 OCD patients without sensory phenomena, and 30 healthy controls will be recruited. Clinical assessments will be conducted, including evaluation of the severity of sensory phenomena, as well as obsessive-compulsive, depressive, and anxiety symptoms. Resting-state functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data will be collected. In addition, during a body-focused video task designed to activate the insula-SMA circuit, task-based fMRI-EEG data will be simultaneously acquired.
Phase 2:
This part adopts a randomized parallel controlled design. Based on the 30 OCD patients with sensory phenomena included in Phase 1, an additional 30 patients will be recruited, resulting in a total of 60 OCD patients with sensory phenomena. After completing baseline clinical scale assessments, behavioral tasks, fMRI, and EEG data collection, participants will be randomly assigned to an on-line group or an off-line group. Both groups will receive low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the Supplementary Motor Area for six consecutive days, with five sessions per day. In the on-line group, participants will watch body-focused sensory videos during each stimulation session, whereas the off-line group will remain at rest during stimulation. After completion of the intervention, clinical scale assessments, behavioral tasks, and fMRI and EEG data collection will be repeated.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- obsessive-compulsive disorder, sensory phenomena, supplementary motor area, insula, neuromodulation
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 1 Hz with a total of 1,200 pulses per session, administered five times per day for six consecutive days. Target localization will be based on each participant's T1-weighted structural MRI, using a neuronavigation system to establish an individualized head model and identify the Supplementary Motor Area. The stimulation intensity will be set at 110% of the individual resting motor threshold (RMT).
| Study group | Role | What they receive |
|---|---|---|
| online group | Experimental | The on-line group will watch body-focused sensory videos during each rTMS session. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| off-line group | Active comparator | The off-line group will remain at rest during each rTMS sessions. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.
Measured: Up to 6 days
Secondary outcomes (8)
Change in Sensory Phenomena Scale (SPS) score
A semi-structured scale used to assess the presence and severity of sensory phenomena occurring before or during repetitive behaviors. It consists of two parts: a symptom checklist and a severity rating.
Measured: Up to 6 days
Change in Beck Depression Inventory(BDI) score
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Measured: Up to 6 days
Change in Beck Anxiety Inventory (BAI) score
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Measured: Up to 6 days
Change in Perceived Stress Scale(PSS) score
It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.
Measured: Up to 6 days
Change in Obsessive-Compulsive Inventory-Revised (OCI-R) score
It is a self-report instrument derived from the original 42-item OCI for assessing obsessive-compulsive symptoms. It contains 18 items divided into six subscales, each with three items, assessing six symptom dimensions: washing, obsessing, hoarding, ordering, checking, and neutralizing. Each item is rated on a 5-point scale from 0 to 4, with higher scores indicating more severe symptoms.
Measured: Up to 6 days
Change in Obsessive Beliefs Questionnaire (OBQ) score
This scale consists of 44 items and includes three factors: responsibility/threat estimation, perfectionism/certainty, and importance/control of thoughts.
Measured: Up to 6 days
Change in Intolerance Of Uncertainty Scale (IUS-12) score
This scale consists of 12 items rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate lower tolerance of uncertainty. The scale includes two dimensions: inhibitory anxiety and prospective anxiety.
Measured: Up to 6 days
Change in Intolerance Of Not Just Right Experiences Questionnaire Revised, (NJRE-Q-R) score
This scale is used to assess the presence and severity of Not Just Right Experiences in individuals.
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayue CHENG, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480408
- Sponsor's protocol ID
- SP-OCD
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of the Insula-Supplementary Motor Area Circuit in Sensory Phenomena in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07480408
- Acronym / sponsor ID
- SP-OCD
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- obsessive-compulsive disorder, sensory phenomena, supplementary motor area, insula, neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 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.
The goal of this clinical study is to investigate the neural mechanisms of abnormal sensory phenomena in patients with Obsessive-Compulsive Disorder and to evaluate whether modulation of the insula-supplementary motor area circuit can improve these symptoms. The study will include adult patients with OCD (with or without sensory phenomena) and healthy volunteers.
The main questions it aims to answer are:
- Do patients with OCD show abnormal activity in the insula-SMA circuit compared with healthy controls?
- Is this abnormality associated with the presence and severity of abnormal sensory phenomena?
- Can low-frequency rTMS targeting the Supplementary Motor Area improve sensory phenomena and obsessive-compulsive symptoms? Researchers will compare an on-line rTMS group (viewing body-focused videos during stimulation) with an off-line rTMS group (resting during stimulation) to evaluate whether task engagement enhances treatment effects.
Participants will:
- Complete clinical assessments and behavioral tasks.
- Undergo EEG and fMRI assessments.
- Receive low-frequency rTMS targeting the Supplementary Motor Area.
- Repeat assessments after the intervention.
Detailed description
Phase 1:
This part adopts a cross-sectional design. A total of 30 patients with Obsessive-Compulsive Disorder with sensory phenomena, 30 OCD patients without sensory phenomena, and 30 healthy controls will be recruited. Clinical assessments will be conducted, including evaluation of the severity of sensory phenomena, as well as obsessive-compulsive, depressive, and anxiety symptoms. Resting-state functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data will be collected. In addition, during a body-focused video task designed to activate the insula-SMA circuit, task-based fMRI-EEG data will be simultaneously acquired.
Phase 2:
This part adopts a randomized parallel controlled design. Based on the 30 OCD patients with sensory phenomena included in Phase 1, an additional 30 patients will be recruited, resulting in a total of 60 OCD patients with sensory phenomena. After completing baseline clinical scale assessments, behavioral tasks, fMRI, and EEG data collection, participants will be randomly assigned to an on-line group or an off-line group. Both groups will receive low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the Supplementary Motor Area for six consecutive days, with five sessions per day. In the on-line group, participants will watch body-focused sensory videos during each stimulation session, whereas the off-line group will remain at rest during stimulation. After completion of the intervention, clinical scale assessments, behavioral tasks, and fMRI and EEG data collection will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online group | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)The on-line group will watch body-focused sensory videos during each rTMS session. |
| off-line group | Active comparator | Device: repetitive transcranial magnetic stimulation (rTMS)The off-line group will remain at rest during each rTMS sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- OCD with abnormal sensory phenomena
- Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Aged 18-55 years.
- Score ≥16 on the Yale-Brown Obsessive Compulsive Scale, indicating moderate to severe symptoms.
- Score >6 on the Sensory Phenomena Scale (SPS), indicating moderate to severe sensory phenomena.
Key exclusion criteria (14 listed)
- Meeting diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for psychiatric disorders other than OCD or obsessive-compulsive personality disorder.
- OCD symptoms so severe that required assessments cannot be completed.
- Presence of severe suicidal ideation or high suicide risk.
- Pregnant women or women planning pregnancy in the near future.
- History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 1 Hz with a total of 1,200 pulses per session, administered five times per day for six consecutive days. Target localization will be based on each participant's T1-weighted structural MRI, using a neuronavigation system to establish an individualized head model and identify the Supplementary Motor Area. The stimulation intensity will be set at 110% of the individual resting motor threshold (RMT). | Device | off-line group, online group |
Primary outcome
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
Time frame: Up to 6 days
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.
8 secondary outcomes
Change in Sensory Phenomena Scale (SPS) score
Time frame: Up to 6 days
Change in Beck Depression Inventory(BDI) score
Time frame: Up to 6 days
Change in Beck Anxiety Inventory (BAI) score
Time frame: Up to 6 days
Change in Perceived Stress Scale(PSS) score
Time frame: Up to 6 days
Change in Obsessive-Compulsive Inventory-Revised (OCI-R) score
Time frame: Up to 6 days
Change in Obsessive Beliefs Questionnaire (OBQ) score
Time frame: Up to 6 days
Change in Intolerance Of Uncertainty Scale (IUS-12) score
Time frame: Up to 6 days
Change in Intolerance Of Not Just Right Experiences Questionnaire Revised, (NJRE-Q-R) score
Time frame: Up to 6 days
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 20 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center 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 14 inclusion and 14 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: opening soon, as of the sponsor's last update on 20 Mar 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?
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 Jiayue Cheng, Master (+8602134773503, chengjy_94@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score (time frame: Up to 6 days). 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 20 Mar 2026.