Treatment-resistant SchizophreniaNCT07773831
Efficacy and Safety of Temporal Interference Stimulation in Treatment-Resistant Schizophrenia: An Exploratory Study.
A study testing Temporal Interference Stimulation in people with Treatment-resistant Schizophrenia, run by Zhimin Wang.
Trial summary
This exploratory study aims to evaluate the preliminary efficacy and safety of temporal interference (TI) stimulation in patients with treatment-resistant schizophrenia (TRS). TI is a noninvasive brain stimulation technique that uses two high-frequency electrical currents with slightly different frequencies to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed male or female participants aged 18 to 65 years, inclusive.
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), established by a psychiatrist at the attending-physician level or above and confirmed by the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2).
- Inadequate response to sequential treatment with at least two antipsychotic medications of different chemical classes, each administered at an adequate dose (≥600 mg/day chlorpromazine equivalents) for an adequate duration (≥6 consecutive weeks at a therapeutic dose).
- Stable dose of antipsychotic medication for at least 4 weeks before enrollment.
- A score of 4 (moderate) or higher on at least two of the following Positive and Negative Syndrome Scale (PANSS) items: delusions, hallucinatory behavior, suspiciousness/persecution, or unusual thought content.
- Ability to understand the study procedures, willingness to participate voluntarily and comply with the study procedures, and provision of written informed consent.
Who cannot join
- Current diagnosis of another major psychiatric disorder other than schizophrenia that, in the investigator's judgment, may confound the diagnosis of schizophrenia or interfere with the assessment of treatment efficacy or safety.
- Receipt of other neuromodulation treatments, including modified electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS), within the previous 3 months, or previous participation in an interventional clinical trial involving vagus nerve stimulation (VNS) or deep brain stimulation (DBS).
- A score ≥3 on Item 3 (suicide) of the 17-item Hamilton Depression Rating Scale (HAMD-17), or a score >3 on any of the following PANSS items: P4 Excitement, G14 Poor Impulse Control, P7 Hostility, or G8 Uncooperativeness.
- Contraindications to magnetic resonance imaging (MRI), including intracranial metallic implants, implanted cardiac pacemakers, or cochlear implants.
- Skull defects or fissures, or inability to tolerate stimulation-related adverse effects.
- Treatment-resistant epilepsy or other serious medical conditions that, in the investigator's judgment, may potentially affect treatment or participation in the study.
- Pregnancy.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
About this study
This exploratory study aims to evaluate the preliminary efficacy and safety of temporal interference (TI) stimulation in patients with treatment-resistant schizophrenia (TRS). TI is a noninvasive brain stimulation technique that uses two high-frequency electrical currents with slightly different frequencies to generate a lower-frequency modulation at a targeted deep brain region.
A total of 20 patients with TRS will receive 130-Hz TI stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day. Participants will continue their stable antipsychotic medication regimen during the study.
Read more
Clinical symptoms, cognitive function, social functioning, and safety will be assessed before treatment, after completion of the 5-day treatment course, and at a 2-week follow-up. The primary clinical outcome is the change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary assessments include PANSS subscale scores, the MATRICS Consensus Cognitive Battery (MCCB), Calgary Depression Scale for Schizophrenia (CDSS), Personal and Social Performance Scale (PSP), and Clinical Global Impression (CGI). Safety will be evaluated through daily monitoring of treatment-related discomfort and adverse events.
Magnetic resonance imaging (MRI) will also be performed before and after treatment to explore treatment-related changes in brain structure, functional activity, functional connectivity, activation, and cerebral blood flow. The study hypothesizes that TI stimulation targeting the ALIC may improve clinical symptoms in patients with TRS and may be associated with measurable changes in neuroimaging markers.
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- Temporal Interference Stimulation
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
Participants with treatment-resistant schizophrenia will receive 130-Hz temporal interference stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day and a 20-minute interval between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Not described Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment
Measured: Baseline to Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 2-Week Follow-up
Measured: Baseline to Day 14 ± 2 days after treatment completion
Secondary outcomes (7)
Change From Baseline in PANSS Positive Symptom Subscale Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in PANSS Negative Symptom Subscale Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in PANSS General Psychopathology Subscale Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in MATRICS Consensus Cognitive Battery (MCCB) Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Personal and Social Performance Scale (PSP) Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Clinical Global Impression (CGI) Score
Measured: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant SchizophreniaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhimin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhimin Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773831
- Sponsor's protocol ID
- CapitalMedicalU
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Temporal Interference Stimulation in Treatment-Resistant Schizophrenia: An Exploratory Study.
- ClinicalTrials.gov ID
- NCT07773831
- Acronym / sponsor ID
- CapitalMedicalU
- Conditions
- Treatment-resistant Schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhimin WangUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Aug 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 exploratory study aims to evaluate the preliminary efficacy and safety of temporal interference (TI) stimulation in patients with treatment-resistant schizophrenia (TRS). TI is a noninvasive brain stimulation technique that uses two high-frequency electrical currents with slightly different frequencies to generate a lower-frequency modulation at a targeted deep brain region.
A total of 20 patients with TRS will receive 130-Hz TI stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day. Participants will continue their stable antipsychotic medication regimen during the study.
Clinical symptoms, cognitive function, social functioning, and safety will be assessed before treatment, after completion of the 5-day treatment course, and at a 2-week follow-up. The primary clinical outcome is the change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary assessments include PANSS subscale scores, the MATRICS Consensus Cognitive Battery (MCCB), Calgary Depression Scale for Schizophrenia (CDSS), Personal and Social Performance Scale (PSP), and Clinical Global Impression (CGI). Safety will be evaluated through daily monitoring of treatment-related discomfort and adverse events.
Magnetic resonance imaging (MRI) will also be performed before and after treatment to explore treatment-related changes in brain structure, functional activity, functional connectivity, activation, and cerebral blood flow. The study hypothesizes that TI stimulation targeting the ALIC may improve clinical symptoms in patients with TRS and may be associated with measurable changes in neuroimaging markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Device: Temporal Interference Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Right-handed male or female participants aged 18 to 65 years, inclusive.
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), established by a psychiatrist at the attending-physician level or above and confirmed by the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2).
- Inadequate response to sequential treatment with at least two antipsychotic medications of different chemical classes, each administered at an adequate dose (≥600 mg/day chlorpromazine equivalents) for an adequate duration (≥6 consecutive weeks at a therapeutic dose).
- Stable dose of antipsychotic medication for at least 4 weeks before enrollment.
- A score of 4 (moderate) or higher on at least two of the following Positive and Negative Syndrome Scale (PANSS) items: delusions, hallucinatory behavior, suspiciousness/persecution, or unusual thought content.
Key exclusion criteria (8 listed)
- Current diagnosis of another major psychiatric disorder other than schizophrenia that, in the investigator's judgment, may confound the diagnosis of schizophrenia or interfere with the assessment of treatment efficacy or safety.
- Receipt of other neuromodulation treatments, including modified electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS), within the previous 3 months, or previous participation in an interventional clinical trial involving vagus nerve stimulation (VNS) or deep brain stimulation (DBS).
- A score ≥3 on Item 3 (suicide) of the 17-item Hamilton Depression Rating Scale (HAMD-17), or a score >3 on any of the following PANSS items: P4 Excitement, G14 Poor Impulse Control, P7 Hostility, or G8 Uncooperativeness.
- Contraindications to magnetic resonance imaging (MRI), including intracranial metallic implants, implanted cardiac pacemakers, or cochlear implants.
- Skull defects or fissures, or inability to tolerate stimulation-related adverse effects.
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 |
|---|---|---|
| Temporal Interference StimulationParticipants with treatment-resistant schizophrenia will receive 130-Hz temporal interference stimulation targeting the anterior limb of the internal capsule (ALIC). Stimulation will be delivered at a total current intensity of 4 mA for 5 consecutive days, with four 40-minute sessions per day and a 20-minute interval between sessions. | Device | Temporal Interference Stimulation |
Primary outcome
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment
Time frame: Baseline to Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 2-Week Follow-up
Time frame: Baseline to Day 14 ± 2 days after treatment completion
7 secondary outcomes
Change From Baseline in PANSS Positive Symptom Subscale Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in PANSS Negative Symptom Subscale Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in PANSS General Psychopathology Subscale Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in MATRICS Consensus Cognitive Battery (MCCB) Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Personal and Social Performance Scale (PSP) Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
Change From Baseline in Clinical Global Impression (CGI) Score
Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion
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 19 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation in people with Treatment-resistant Schizophrenia, run by Zhimin Wang.
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 6 inclusion and 8 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment (time frame: Baseline to Day 5). 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?
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 19 Aug 2026.