The Effect of tDCS on Schizophrenia With Negative Symptoms
2019년 10월 2일 업데이트: Tae Young Lee, MD, Seoul National University Hospital
Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
The investigators conducted a randomized controlled trial to reveal the effect of tDCS on negative symptoms in patients with schizophrenia and its underlying mechanism using the neuroimaging and electrophysiology.
연구 개요
상세 설명
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.
Using anodal and cathodal tDCS the investigators aimed to treat negative symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 44 patients (22 in each group). 44 patients will be included in Seoul National University Hospital
연구 유형
중재적
등록 (예상)
44
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seoul, 대한민국
- Seoul National University Hospital
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- DSM-IV Schizophrenia
- 1 or more items of Negative symptom score in PANSS > 5
Exclusion Criteria:
- presences of neurological disorder or history
- IQ < 70
- presence of severe personality disorders
- presence of substance use disorder (except nicotin)
- pregnancy
- presence of severe medical condition or disorders
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: actual tDCS
2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
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Transcranial direct current stimulation (tDCS) is a form of neurostimulation that uses constant, low direct current delivered via electrodes on the head.
It can be contrasted with cranial electrotherapy stimulation, which generally uses alternating current the same way
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활성 비교기: sham tDCS
sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
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Transcranial direct current stimulation (tDCS) is a form of neurostimulation that uses constant, low direct current delivered via electrodes on the head.
It can be contrasted with cranial electrotherapy stimulation, which generally uses alternating current the same way
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Positive and Negative Syndrome Scale (PANSS)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in psychopathology To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted.
The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers
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approximately 2 weeks (baseline and 2 weeks followups)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Clinical Assessment Interview for Negative Symptoms (CAINS)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in psychopathology The CAINS is a clinical rating scale for negative symptoms with potent and clear treatment targets for the next generation of pharmacological and psychosocial treatments.
It rangs between 0 to 52
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approximately 2 weeks (baseline and 2 weeks followups)
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Electroencephalography - resting
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in lagged phase synchronization and microstate connectivity
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approximately 2 weeks (baseline and 2 weeks followups)
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Electroencephalography - P300
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in P300
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approximately 2 weeks (baseline and 2 weeks followups)
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Electroencephalography - MMN
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in MMN
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approximately 2 weeks (baseline and 2 weeks followups)
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Electroencephalography - ERN
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in ERN
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - grey matter volume
기간: approximately 2 weeks (baseline and 2 weeks followups)
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change in grey matter volume
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - cortical thickness
기간: approximately 2 weeks (baseline and 2 weeks followups)
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change in cortical thickness
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - cortical surface area
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in MRI - cortical thickness
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - cortical gyrification
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in cortical gyrification
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approximately 2 weeks (baseline and 2 weeks followups)
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DTI - mean diffusivity (MD)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in MD
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approximately 2 weeks (baseline and 2 weeks followups)
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DTI - axial diffusivity (AD)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in AD
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approximately 2 weeks (baseline and 2 weeks followups)
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DTI - radial diffusivity (RD)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in RD
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approximately 2 weeks (baseline and 2 weeks followups)
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DTI - fractional anisotropy (FA)
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in FA
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - rsfMRI
기간: approximately 2 weeks (baseline and 2 weeks followups)
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change in BOLD signals
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approximately 2 weeks (baseline and 2 weeks followups)
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MRI - MRS
기간: approximately 2 weeks (baseline and 2 weeks followups)
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Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
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approximately 2 weeks (baseline and 2 weeks followups)
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fNIRS
기간: approximately 2 weeks (baseline and 2 weeks followups)
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change in level of the Oxy-Hemoglobin
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approximately 2 weeks (baseline and 2 weeks followups)
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Korean Wechsler Adult Intelligence Scale (K-WAIS)
기간: baseline
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baseline total Intelligence quotient value
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baseline
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Spatial Working Memory
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in the spatial working memory ability
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approximately 2 weeks (baseline and 2 weeks followups)
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California Verbal Learning Test
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in verbal learning ability
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approximately 2 weeks (baseline and 2 weeks followups)
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Letter/Category fluency test
기간: approximately 2 weeks (baseline and 2 weeks followups)
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changes in fluency ability
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approximately 2 weeks (baseline and 2 weeks followups)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Tae Young Lee, MD, Seoul National University Hospital
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 (예상)
2019년 12월 1일
기본 완료 (예상)
2020년 12월 1일
연구 완료 (예상)
2020년 12월 1일
연구 등록 날짜
최초 제출
2018년 10월 30일
QC 기준을 충족하는 최초 제출
2018년 10월 31일
처음 게시됨 (실제)
2018년 11월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 2일
마지막으로 확인됨
2019년 10월 1일
추가 정보
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. .
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