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Recruiting NCT07446478

TIS for Improving Cognitive Impairment Associated With Schizophrenia

No phase Interventional Cognitive Impairment Associated With Schizophrenia (CIAS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: temporal interference stimulation.
Who it may be relevant to
Registry conditions: Cognitive Impairment Associated With Schizophrenia (CIAS). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia

Overview

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.

Interventions

  • Device temporal interference stimulation
    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.

Primary outcome measures

  • changes on MCCB scores [Time frame: Baseline, after 2-week intervention]
Secondary outcome measures (7)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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%;
  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Xiangya Hospital, Central South University — Changsha

Identifiers

NCT: NCT07446478 · TIS20260106 · 82325020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗