An interventional study of temporal interference stimulation in Cognitive Impairment Associated With Schizophrenia (CIAS), sponsored by Central South University. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Central South University · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
TI group will be administered temporal interference stimulation
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.
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.
Time frame: Baseline, after 2-week intervention
Changes in Positive and Negative Symptom Scale (PANSS) scores
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10.
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Central South University