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TIS for Improving Cognitive Impairment in Schizophrenia

2026년 6월 9일 업데이트: Renrong Wu, Central South University

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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Schizophrenia is a chronic psychiatric disorder that imposes a substantial and increasing global disease burden. Cognitive impairment associated with schizophrenia (CIAS) is a core deficit that strongly predicts global function and quality of life. While effective for positive symptoms, antipsychotics cannot meet treatment requirements on CIAS and are limited by severe metabolic and extrapyramidal side effects. Consequently, there is an urgent need to explore effective treatments for CIAS.

Non-invasive brain stimulation (NIBS), including TMS and TES, has emerged as a promising adjunctive therapy for CIAS by modulating cortical excitability and neuroplasticity. However, conventional NIBS is constrained by limited focal depth, indirectly influencing subcortical circuits. Temporal Interference Stimulation (TIS) overcomes these limitations by utilizing intersecting high-frequency electric fields to generate a low-frequency envelope, enabling the selective modulation of deep neural targets while sparing the superficial cortex. TIS offers superior spatial precision and tolerability for treating neuropsychiatric disorders involving deep-circuit dysfunction.

Neurophysiological evidence implicates glutamatergic dysregulation and excitatory-inhibitory (E/I) imbalance as key mechanisms in schizophrenia. Hippocampal hyperactivity enhances excitatory drive to the prefrontal cortex, disrupting cortico-hippocampal communication, attenuating γ-band oscillations, and impairing network synchrony that supports working memory and executive processes.

Recent studies in healthy individuals demonstrate that 5 Hz TIS targeting the left anterior hippocampus enhances episodic memory and hippocampal-prefrontal connectivity. Intermittent theta-burst stimulation (iTBS) of the right hippocampus improves spatial memory. Only one pilot study in schizophrenia has examined high-frequency (130 Hz) TIS targeting the right nucleus accumbens, showing improvements in negative and cognitive symptoms.

This study aims to evaluate the efficacy and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating CIAS.

We will conduct a randomized controlled clinical trial. 50 participants with schizophrenia (25 in each group) will be recruited and randomly assigned to an active treatment group or a sham treatment group. The intervention will be given twice a day for 2 weeks. The changes in clinical symptoms, cognitive function, E/I imbalance, and brain structure and function will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention to explore the short-term efficacy, safety, and neurobiological mechanism of TIS in improving cognitive function in schizophrenia.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Hunan
      • Changsha, Hunan, 중국, 410011
        • Second Xiangya Hospital, Central South University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Active TIS
Active TIS group will be administered active temporal interference stimulation
장치: 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.
가짜 비교기: sham TIS
Sham TIS group will be administered sham temporal interference stimulation
장치: Sham stimulation
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
changes on MCCB scores
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
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

2차 결과 측정

결과 측정
측정값 설명
기간
뇌 기능 변화
기간: 기준선, 2주간의 중재 후
기능적 자기공명영상(fMRI)은 혈액 산소 농도 의존적(BOLD) 대조를 기반으로 하여, 혈액 산소화 변화를 감지하여 중재 후 뇌 기능 변화를 분석할 수 있습니다.
기준선, 2주간의 중재 후
Changes in Positive and Negative Symptom Scale (PANSS) scores
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Baseline, after 2-week intervention, 4 weeks post-treatment
Change in Scale for Assessment of Negative Symptoms (SANS) score
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The score range is 0-120; the higher the score, the more severe the negative symptoms are.
Baseline, after 2-week intervention, 4 weeks post-treatment
Changes in Calgary Depression Scale for Schizophrenia (CDSS) score
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
Ranges from 0 to 27; a higher score indicates more severe affective symptoms.
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on neuroelectrophysiological signals
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The changes of neuroelectrophysiological signals were collected under the task-based electroencephalogram.
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on global function
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
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.
Baseline, after 2-week intervention, 4 weeks post-treatment
changes in social function.
기간: Baseline, 4 weeks post-treatment
Social function will be assessed by the Global Functioning: Social (GF:Social) and Role (GF:Role) scales (GFS) and the Social Functioning Scale (SFS). The GFS is a clinician-rated, 1-10 point tool designed to measure social and occupational functioning. They focus on development, allowing for the assessment of change over time, and avoid confounding functioning with psychiatric symptoms. The SFS is a 79-item self-report measure designed to assess social functioning in schizophrenia. Items assess ability and performance related to social engagement, interpersonal contact, recreation, independence and competence in activities, activities of daily living, and employment.
Baseline, 4 weeks post-treatment
changes on aperiodic 1/f-like signal exponent
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The aperiodic component of the neural power spectrum, quantified as the slope of the 1/f-like signal recorded by electroencephalogram, will be used as an index of excitation/inhibition balance. The unit of measure is the exponent (unitless).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on long-range temporal correlations (LRTCs)
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
Long-range temporal correlations of neural oscillations recorded by electroencephalogram will be measured as an index of the temporal stability of excitation/inhibition balance. The unit of measure is the Hurst exponent (unitless).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on functional E/I ratio
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The ratio of excitatory to inhibitory neural activity derived from electroencephalogram signals will be calculated as a functional excitation/inhibition balance index. The unit of measure is a ratio (unitless).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on oscillation power across all frequency bands
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The power of neural oscillations across all frequency bands (e.g., delta, theta, alpha, beta, gamma) recorded by electroencephalogram will be measured. The power values from all bands will be averaged to produce a single composite oscillation power index. The unit of measure is microvolts squared (μV²).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on 40 Hz auditory steady-state responses (40Hz-ASSRs)
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The 40 Hz auditory steady-state responses recorded by electroencephalogram will be measured, including both evoked power and inter-trial phase coherence. The unit of measure for evoked power is μV², and the unit of measure for phase coherence is unitless.
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on mismatch negativity (MMN)
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The mismatch negativity amplitude recorded by electroencephalogram using an oddball paradigm will be measured. The unit of measure is microvolts (μV).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on P300 event-related potential
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
The P300 amplitude recorded by electroencephalogram using an oddball paradigm will be measured. The unit of measure is microvolts (μV).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on behavioral performance - Sternberg Item-Recognition Paradigm
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
Behavioral performance will be evaluated using the Sternberg Item-Recognition Paradigm, a memory task that measures reaction time and accuracy. The unit of measure for reaction time is milliseconds (ms), and the unit of measure for accuracy is percentage correct (%).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on behavioral performance - Mnemonic Similarity Task
기간: Baseline, after 2-week intervention, 4 weeks post-treatment
Behavioral performance will be evaluated using the Mnemonic Similarity Task, a memory task that measures pattern separation and recognition memory. Three indices will be derived and reported separately: the Lure Discrimination Index (LDI), the similarity object recognition index, and the old object recognition index. All three indices are measured in d-prime (unitless).
Baseline, after 2-week intervention, 4 weeks post-treatment
changes on peripheral blood allostatic load index
기간: Baseline, 4 weeks post-treatment
Approximately 10 mL of blood will be collected intravenously to measure peripheral blood biomarkers: brain-derived neurotrophic factor (BDNF) in ng/mL, C-reactive protein (CRP) in mg/L, interleukin-6 (IL-6) in pg/mL, Kynurenic acid in nM, high-density lipoprotein (HDL) in mg/dL, low-density lipoprotein (LDL) in mg/dL, and triglycerides (TG) in mg/dL. These biomarkers will be combined into a single allostatic load index using a standardized high-risk count algorithm. For each biomarker, a cutoff score based on population norms or clinical thresholds (e.g., highest-risk quartile) will be applied to determine high-risk status (1 = high-risk, 0 = not high-risk). The allostatic load score is the sum of high-risk indicators across all biomarkers. The unit of measure is the allostatic load score (unitless, integer count).
Baseline, 4 weeks post-treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Central South University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 30일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 30일

연구 등록 날짜

최초 제출

2026년 2월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TIS20250606
  • 82325020 (기타 보조금/기금 번호: National Natural Science Foundation of China)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

temporal interference stimulation에 대한 임상 시험

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