TIS for Improving Cognitive Impairment in Schizophrenia
Recruiting · NCT07647380 · Interventional (participants receive a specific treatment) · Lead sponsor: Central South University
View the official record on ClinicalTrials.gov →Interventions studied
Sham stimulationtemporal interference stimulation
What this trial is about
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.
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Second Xiangya Hospital, Central South University - Changsha, Hunan, China