Cognitive Impairment Associated With Schizophrenia (CIAS)NCT07446478
TIS for Improving Cognitive Impairment Associated With Schizophrenia
A study testing temporal interference stimulation in people with Cognitive Impairment Associated With Schizophrenia (CIAS), run by Central South University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cognitive Impairment Associated With Schizophrenia (CIAS)
- What is being tested?
- temporal interference stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2026to 20 Sep 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years old;
- meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;
- the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
- the disease duration does not exceed 8 years;
- 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed;
- The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;
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- Impaired functioning in daily activities;
- The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;
- Agree to participate in this study and provide written informed consent
Who cannot join
- Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco);
- with clear drug-induced extrapyramidal reaction;
- A history of seizures, meningitis, or encephalitis;
- with contraindications to transcranial electrical stimulation;
- History of intracranial tumors or surgery;
- history of severe head trauma;
- have received other regimens of electrical or magnetic therapy in 1 month before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
About this study
Official title: Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia
This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.
Read the detailed description
Cognitive impairment associated with schizophrenia (CIAS) remains a therapeutic challenge, as conventional antipsychotics and depth-limited neurostimulation (NIBS) fail to address the subcortical dysregulation that drives cognitive dysfunction. Temporal Interference Stimulation (TIS) overcomes these biophysical limitations by using intersecting high-frequency electric fields to non-invasively target deep structures such as the hippocampus with great spatial accuracy. Due to its potential to enhance the synchronization between the hippocampus and the prefrontal cortex, TIS offers a new prospect for treating CIAS.
This single-arm, open-label trial will evaluate the efficacy of hippocampal-targeted TIS in patients with schizophrenia. Participants will undergo a 10-day intervention (twice daily) and will be assessed using clinical, cognitive (MCCB), and neuroimaging (rs-fMRI) tests at baseline and post-intervention.
- Being tested
- temporal interference stimulation
- Keywords
- schizophrenia, cognitive impairments, temporal interference stimulation
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporal interference stimulationDevice
TIS will use 2 pairs of electrodes placed according to a 10-10 EEG system and fixed with conductive paste to produce a theta burst stimulation pattern. Electric field modeling will be performed utilizing MRI T1 images to optimize the individualized electrode configuration to generate electric field intensities above 0.6 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| TI | Experimental | TI group will be administered temporal interference stimulation Receives: Device: temporal interference stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes on MCCB scores
The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
Measured: Baseline, after 2-week intervention
Secondary outcomes (7)
Changes in Positive and Negative Symptom Scale (PANSS) scores
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Measured: Baseline, after 2-week intervention
Change in Scale for Assessment of Negative Symptoms (SANS) score
The score range is 0-120; the higher the score, the more severe the negative symptoms are.
Measured: Baseline, after 2-week intervention
Changes in Psychotic symptom rating scales (PSYRATS) score
The Psychotic Symptom Rating Scales (PSYRATS) is a clinician-rated instrument that assesses the multidimensional severity of auditory hallucinations and delusions. It consists of two subscales: an 11-item Hallucinations subscale (total score range 0-44) and a 6-item Delusions subscale (total score range 0-24), with each item rated from 0 to 4. A higher score indicates more severe auditory hallucinations and delusions.
Measured: Baseline, after 2-week intervention
Changes in brain function
Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.
Measured: Baseline, after 2-week intervention
changes on behavioral performance
Behavioral performance will be evaluated by memory task, including Sternberg Item-Recognition Paradigm and mnemonic similarity task.
Measured: Baseline, after 2-week intervention
changes of global function.
Global function will be measured by the Global Assessment of Functioning (GAF). GAF is a 0-100 numerical scale used by clinicians to subjectively rate a person's overall psychological, social, and occupational functioning. Higher scores (91-100) indicate superior functioning, while lower scores (1-10) indicate severe danger or impairment.
Measured: Baseline, after 2-week intervention
adverse event incidences
The adverse event recording form (AERF) includes common adverse reactions induced by TIS. Each item is between 1 (absent) and 4 (severe). A higher score indicates a more severe adverse event.
Measured: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Jun 2026
- Primary completion16 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment Associated With Schizophrenia (CIAS)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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446478
- Sponsor's protocol ID
- TIS20260106
- Other IDs
- 82325020
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia
- ClinicalTrials.gov ID
- NCT07446478
- Acronym / sponsor ID
- TIS20260106
- Keywords
- schizophrenia, cognitive impairments, temporal interference stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 3 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.
This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.
Detailed description
Cognitive impairment associated with schizophrenia (CIAS) remains a therapeutic challenge, as conventional antipsychotics and depth-limited neurostimulation (NIBS) fail to address the subcortical dysregulation that drives cognitive dysfunction. Temporal Interference Stimulation (TIS) overcomes these biophysical limitations by using intersecting high-frequency electric fields to non-invasively target deep structures such as the hippocampus with great spatial accuracy. Due to its potential to enhance the synchronization between the hippocampus and the prefrontal cortex, TIS offers a new prospect for treating CIAS.
This single-arm, open-label trial will evaluate the efficacy of hippocampal-targeted TIS in patients with schizophrenia. Participants will undergo a 10-day intervention (twice daily) and will be assessed using clinical, cognitive (MCCB), and neuroimaging (rs-fMRI) tests at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TI | Experimental | Device: temporal interference stimulationTI group will be administered temporal interference stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-50 years old;
- meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;
- the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
- the disease duration does not exceed 8 years;
- 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed;
Key exclusion criteria (7 listed)
- Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco);
- with clear drug-induced extrapyramidal reaction;
- A history of seizures, meningitis, or encephalitis;
- with contraindications to transcranial electrical stimulation;
- History of intracranial tumors or surgery;
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 stimulationTIS will use 2 pairs of electrodes placed according to a 10-10 EEG system and fixed with conductive paste to produce a theta burst stimulation pattern. Electric field modeling will be performed utilizing MRI T1 images to optimize the individualized electrode configuration to generate electric field intensities above 0.6 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes. | Device | TI |
Primary outcome
changes on MCCB scores
Time frame: Baseline, after 2-week intervention
The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
7 secondary outcomes
Changes in Positive and Negative Symptom Scale (PANSS) scores
Time frame: Baseline, after 2-week intervention
Change in Scale for Assessment of Negative Symptoms (SANS) score
Time frame: Baseline, after 2-week intervention
Changes in Psychotic symptom rating scales (PSYRATS) score
Time frame: Baseline, after 2-week intervention
Changes in brain function
Time frame: Baseline, after 2-week intervention
changes on behavioral performance
Time frame: Baseline, after 2-week intervention
changes of global function.
Time frame: Baseline, after 2-week intervention
adverse event incidences
Time frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10.
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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 temporal interference stimulation in people with Cognitive Impairment Associated With Schizophrenia (CIAS), run by Central South 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 9 inclusion and 7 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 23 Sep 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?
changes on MCCB scores (time frame: Baseline, after 2-week intervention). 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 23 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.