Obsessive-Compulsive Disorder (OCD)NCT07113652
The Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
A study testing TI stimulation device (nerviox-1000） in people with Obsessive-Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- TI stimulation device (nerviox-1000）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2025to Jun 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years old
- Diagnosis of OCD per DSM-5
- Y-BOCS score ≥20
- Have a documented history of at least two adequate trials of selective serotonin reuptake inhibitors (SSRIs). If currently receiving SSRI treatment, the dosage must be stable for at least 8 weeks prior to enrollment
- With at least 9 years of education
Who cannot join
- Any DSM-5 diagnosis other than OCD (except OCPD)
- OCD symptoms too severe to complete assessments
- Received electroconvulsive therapy (ECT) within the past 6 months
- Received other forms of neuromodulation within the past 2 months（see Item 3 for ECT）
- Severe medical illness or seizure risk (e.g., cardiovascular, respiratory conditions)
- Neurological disorders or history of brain injury/surgery
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- MRI-incompatible implants (e.g., pacemaker, stents, cochlear implants).
- Current suicidal risk per investigator judgment
- Pregnant or planning pregnancy during the study
- Started structured OCD psychotherapy within 3 months, with expected change during treatment
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, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Zhen Wang, Phd, MD, +86 34773516, wangzhen@smhc.org.cn
About this study
Official title: Exploring the Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG).
Read the detailed description
This randomized, blind, multi-phase clinical trial aims to evaluate the efficacy of Temporal Interference (TI) stimulation in patients with treatment obsessive-compulsive disorder (OCD), and to compare the effects of stimulating different brain regions.
The study includes three phases:
- Phase 1: Patients are randomly assigned to receive either sham stimulation, bilateral nucleus accumbens (NAcc) stimulation, or bilateral bed nucleus of the stria terminalis (BNST) stimulation.
- Phase 2: Non-responders from Phase 1 enter a second phase, receiving stimulation to the opposite target region. Sham participants are re-randomized to NAcc or BNST.
- Phase 3 (Exploratory): Remaining non-responders may opt to receive stimulation targeting the caudate nucleus, the putamen, or the amygdala.
Stimulation is delivered twice daily for 7 days in each phase, followed by follow-up assessments for up to 4 weeks. Comprehensive clinical assessments, self-reported symptom scales, magnetic resonance imaging (MRI), electroencephalography (EEG), and cognitive function tests are conducted before and after each phase to ensure data consistency. Additionally, clinical assessments and self-reported scales are repeated 1 week after the end of each treatment phase.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- TI stimulation device (nerviox-1000）
- 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.
TI stimulation device (nerviox-1000）Device
The TI stimulation device (nerviox-1000) delivers temporally interfering electrical fields with a 130 Hz envelope frequency, generated by high-frequency carrier waves. The stimulation is applied for 20 minutes per session, with a peak current of 3-4 mA per channel, adjusted based on individual tolerance. The stimulation targets include the nucleus accumbens, bed nucleus of the stria terminalis, amygdala, caudate nucleus, and putamen. Stimulation is administered twice daily, with each treatment phase lasting 7 consecutive days.
Sham stimulation uses identical electrode placement and setup as active stimulation. A brief 30-second ramp-up is applied to mimic real stimulation, followed by rapid reduction to 0 mA or minimal current. A 1 mA "tail" current is delivered in the final 30 seconds to simulate the tapering effect of active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group | Other | Participants assigned to NAcc-BNST group will receive stimulation targeting the NAcc in Phase 1 and the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. Receives: Device: TI stimulation device (nerviox-1000） |
| Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group | Other | Participants assigned to BNST-NAcc group will receive stimulation targeting the BNST in Phase 1 and the NAcc in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. Receives: Device: TI stimulation device (nerviox-1000） |
| Sham Group-NAcc Group or BNST Group-Exploratory group | Other | Participants assigned to the Sham-NAcc or Sham-BNST groups will receive sham stimulation in Phase 1, followed by active stimulation targeting the NAcc or the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. Receives: Device: TI stimulation device (nerviox-1000） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms improvement
Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a 10-item clinician-rated scale with a total score range of 0 to 40. Higher total scores indicate more severe obsessive-compulsive symptoms.
Measured: phase-specific baseline and 1 week after the end of each phase of TI treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start17 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113652
- Sponsor's protocol ID
- SMHC-OCD-018
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07113652
- Acronym / sponsor ID
- SMHC-OCD-018
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 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.
This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed description
This randomized, blind, multi-phase clinical trial aims to evaluate the efficacy of Temporal Interference (TI) stimulation in patients with treatment obsessive-compulsive disorder (OCD), and to compare the effects of stimulating different brain regions.
The study includes three phases:
- Phase 1: Patients are randomly assigned to receive either sham stimulation, bilateral nucleus accumbens (NAcc) stimulation, or bilateral bed nucleus of the stria terminalis (BNST) stimulation.
- Phase 2: Non-responders from Phase 1 enter a second phase, receiving stimulation to the opposite target region. Sham participants are re-randomized to NAcc or BNST.
- Phase 3 (Exploratory): Remaining non-responders may opt to receive stimulation targeting the caudate nucleus, the putamen, or the amygdala.
Stimulation is delivered twice daily for 7 days in each phase, followed by follow-up assessments for up to 4 weeks. Comprehensive clinical assessments, self-reported symptom scales, magnetic resonance imaging (MRI), electroencephalography (EEG), and cognitive function tests are conducted before and after each phase to ensure data consistency. Additionally, clinical assessments and self-reported scales are repeated 1 week after the end of each treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group | Other | Device: TI stimulation device (nerviox-1000）Participants assigned to NAcc-BNST group will receive stimulation targeting the NAcc in Phase 1 and the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. |
| Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group | Other | Device: TI stimulation device (nerviox-1000）Participants assigned to BNST-NAcc group will receive stimulation targeting the BNST in Phase 1 and the NAcc in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. |
| Sham Group-NAcc Group or BNST Group-Exploratory group | Other | Device: TI stimulation device (nerviox-1000）Participants assigned to the Sham-NAcc or Sham-BNST groups will receive sham stimulation in Phase 1, followed by active stimulation targeting the NAcc or the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-50 years old
- Diagnosis of OCD per DSM-5
- Y-BOCS score ≥20
- Have a documented history of at least two adequate trials of selective serotonin reuptake inhibitors (SSRIs). If currently receiving SSRI treatment, the dosage must be stable for at least 8 weeks prior to enrollment
- With at least 9 years of education
Key exclusion criteria (10 listed)
- Any DSM-5 diagnosis other than OCD (except OCPD)
- OCD symptoms too severe to complete assessments
- Received electroconvulsive therapy (ECT) within the past 6 months
- Received other forms of neuromodulation within the past 2 months（see Item 3 for ECT）
- Severe medical illness or seizure risk (e.g., cardiovascular, respiratory conditions)
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 |
|---|---|---|
| TI stimulation device (nerviox-1000）The TI stimulation device (nerviox-1000) delivers temporally interfering electrical fields with a 130 Hz envelope frequency, generated by high-frequency carrier waves. The stimulation is applied for 20 minutes per session, with a peak current of 3-4 mA per channel, adjusted based on individual tolerance. The stimulation targets include the nucleus accumbens, bed nucleus of the stria terminalis, amygdala, caudate nucleus, and putamen. Stimulation is administered twice daily, with each treatment phase lasting 7 consecutive days. Sham stimulation uses identical electrode placement and setup as active stimulation. A brief 30-second ramp-up is applied to mimic real stimulation, followed by rapid reduction to 0 mA or minimal current. A 1 mA "tail" current is delivered in the final 30 seconds to simulate the tapering effect of active stimulation. | Device | Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group, Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group, Sham Group-NAcc Group or BNST Group-Exploratory group |
Primary outcome
Obsessive-compulsive symptoms improvement
Time frame: phase-specific baseline and 1 week after the end of each phase of TI treatment
Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a 10-item clinician-rated scale with a total score range of 0 to 40. Higher total scores indicate more severe obsessive-compulsive symptoms.
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 10 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI stimulation device (nerviox-1000） in people with Obsessive-Compulsive Disorder (OCD), 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 5 inclusion and 10 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 10 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 Zhen Wang, PhD,MD (+86 34773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive symptoms improvement (time frame: phase-specific baseline and 1 week after the end of each phase of TI 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 10 Mar 2026.