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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the efficacy, safety, and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Researchers will compare active TIS to a sham control to see if TIS works to treat CIAS. Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, E/I imbalance index recorded by EEG, and MRI data, will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Renrong Wu
wurenrong@csu.edu.cn
15874179855
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 50
Treatments
Experimental: Active TIS
Active TIS group will be administered active temporal interference stimulation
Sham_comparator: sham TIS
Sham TIS group will be administered sham temporal interference stimulation
Related Therapeutic Areas
Sponsors
Leads: Central South University

This content was sourced from clinicaltrials.gov