TIS for Improving Cognitive Impairment in Schizophrenia

NCT07647380 | Not Yet Recruiting DMC

• 2 other identifiers: TIS2025060682325020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia Disorder; Cognitive Impairments

Keywords

schizophrenia; cognitive impairments; temporal interference stimulation; excitatory-inhibitory imbalance

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, after 2-week intervention, 4 weeks post-treatment

Secondary Outcomes (17)

• Changes in Positive and Negative Symptom Scale (PANSS) scores

  Baseline, after 2-week intervention, 4 weeks post-treatment

• Change in Scale for Assessment of Negative Symptoms (SANS) score

  Baseline, after 2-week intervention, 4 weeks post-treatment

• Changes in Calgary Depression Scale for Schizophrenia (CDSS) score

  Baseline, after 2-week intervention, 4 weeks post-treatment

• Changes in brain function

  Baseline, after 2-week intervention

• changes on neuroelectrophysiological signals

  Baseline, after 2-week intervention, 4 weeks post-treatment

Study Arms (2)

Active TIS

EXPERIMENTAL

Active TIS group will be administered active temporal interference stimulation

Device: temporal interference stimulation

sham TIS

SHAM COMPARATOR

Sham TIS group will be administered sham temporal interference stimulation

Device: Sham stimulation

Interventions

temporal interference stimulation DEVICE

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.

Active TIS

Sham stimulation DEVICE

The sham stimulation only includes a 15-second ramp-up at the start and ramp-down at the beginning of each stimulus, which could simulate the scalp pulsing sensation caused by the change of current at the beginning and end of the stimulus.

sham TIS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Renrong Wu

CONTACT

15874179855; wurenrong@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatment operator will maintain a randomization form containing the specific randomization identification number and the treatment assignment code of each participant. The treatment operator is not involved in other processes of this study. After the participants complete the screening and baseline assessment, they will be assigned a randomization identification number, and the treatment operator will check the corresponding treatment assignment code and provide the appropriate treatment. Neither the investigators who assessed the efficacy nor the participants will be aware of the treatment assignments. Meanwhile, participants will be instructed by the investigator not to discuss their treatment assignment with study staff members or other participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: June 15, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)