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Not yet recruitingNCT07773831Updated Aug 19, 2026

Efficacy and Safety of Temporal Interference Stimulation in Treatment-Resistant Schizophrenia: An Exploratory Study.

An interventional study of Temporal Interference Stimulation in Treatment-resistant Schizophrenia, sponsored by Zhimin Wang. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Zhimin Wang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Treatment-resistant Schizophrenia
03

In context

Schizophrenia, Treatment-Resistant

53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.

Browse Schizophrenia, Treatment-Resistant studies →

Lead sponsor

This is the only study on the registry with Zhimin Wang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Right-handed male or female participants aged 18 to 65 years, inclusive.
  2. Diagnosis of schizophrenia according to the , 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).
  3. 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).
  4. Stable dose of antipsychotic medication for at least 4 weeks before enrollment.
  5. 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.
  6. Ability to understand the study procedures, willingness to participate voluntarily and comply with the study procedures, and provision of written .

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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).
  3. 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.
  4. to magnetic resonance imaging (MRI), including intracranial metallic implants, implanted cardiac pacemakers, or cochlear implants.
  5. Skull defects or fissures, or inability to tolerate stimulation-related adverse effects.
  6. Treatment-resistant epilepsy or other serious medical conditions that, in the investigator's judgment, may potentially affect treatment or participation in the study.
  7. Pregnancy.
  8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Temporal Interference Stimulation

    Device: Temporal Interference Stimulation

Interventions

  • DeviceTemporal Interference Stimulation

    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.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment

    Time frame: Baseline to Day 5

  2. 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

Secondary outcomes

  1. Change From Baseline in PANSS Positive Symptom Subscale Score

    Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion

  2. Change From Baseline in PANSS Negative Symptom Subscale Score

    Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion

  3. Change From Baseline in PANSS General Psychopathology Subscale Score

    Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion

  4. Change From Baseline in MATRICS Consensus Cognitive Battery (MCCB) Score

    Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion

  5. 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

  6. 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

  7. Change From Baseline in Clinical Global Impression (CGI) Score

    Time frame: Baseline to Day 5 and Day 14 ± 2 days after treatment completion

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for May 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2026
First posted
Aug 19, 2026
StartEst.
Aug 2026
Primary completionEst.
May 2027
CompletionEst.
Jul 2027
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07773831
Lead sponsor
Zhimin Wang
Responsible party
Zhimin Wang (Chief Physician, Capital Medical University) — Sponsor-investigator
First posted
Aug 19, 2026
Start date
Aug 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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