NCT07446478

TIS for Improving Cognitive Impairment Associated With Schizophrenia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Cognitive Impairment Associated With Schizophrenia (CIAS)

Interventions

Type	Name	Description
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 0.4 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-05-01
• Completion: 2026-05-15
• First posted: 2026-03-03
• Last updated: 2026-03-17

Locations

1 site across 1 country: China