- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07637773
Investigating the Efficacy and Mechanisms of Individualized tACS Targeting Anhedonia in Late-Life Depression
Efficacy and Mechanisms of Personalized tACS Targeting Anhedonia in Late-Life Depression
연구 개요
상태
상세 설명
This project aims to explore effective treatment strategies and mechanisms of action for personalized transcranial alternating current stimulation (tACS) targeting anhedonia in late-life depression (LLD). Late-life depression has a high prevalence, with 70% of patients exhibiting symptoms of anhedonia, which is
. Current pharmacological treatments face challenges such as poor response rates and significant side effects, creating an urgent need for novel intervention strategies. As a non-invasive neurostimulation technique, tACS can improve depressive symptoms by modulating brain oscillatory activity; however, personalized treatment protocols and mechanisms specifically targeting anhedonia in LLD remain unclear. By optimizing tACS parameters, validating clinical efficacy, and elucidating the underlying neural mechanisms, this project will fill a research gap in this field. The findings will not only provide safe and effective non-pharmacological treatment options for patients with geriatric depression, thereby reducing suicide risk, but will also advance the application of tACS technology in precision medicine for mental disorders, holding significant clinical value and social implications.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Daliang Sun Da liang Sun, Doctor
- 전화번호: +86 88188876
- 이메일: 474929588@qq.com
연구 장소
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300222
- 모병
- Tianjin Anding Hospital
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연락하다:
- Daliang Sun, Doctor
- 전화번호: +86 88188876
- 이메일: 474929588@qq.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- (1) Patients were interviewed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Clinical Version (SCID-5-CV) to confirm that they met the DSM-5 diagnostic criteria for "major depressive disorder"; (2) Age ≥ 60 years; gender not restricted; (3) Hamilton Depression Scale (HAMD)-17 score > 24
Exclusion Criteria:
- (1) History of severe head trauma or serious neurological conditions such as epilepsy; (2) Any brain devices or implants, including cochlear implants and aneurysm clips; treatments such as transcranial direct current stimulation (tDCS).
(3) Individuals who have undergone other physical modulation therapies within the past 8 weeks, including but not limited to non-convulsive electroconvulsive therapy, repetitive transcranial magnetic stimulation, and transcranial direct current stimulation.
공부 계획
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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활성 비교기: active
The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode.
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divided into a real-stimulus group and a sham-stimulus group
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가짜 비교기: shame
The peak-to-peak amplitude was 1 mA at 40 Hz (tACS), with a frequency and a sinusoidal stimulation waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 international EEG electrode placement system, with CZ serving as the return electrode, shame arm is not biologically active.
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The sham tACS group received 40 Hz tACS with a peak-to-peak amplitude of 1 mA, a frequency of y, and a sinusoidal waveform.
The stimulation sites were located in the prefrontal cortex (F3 and F4) based on the 10-20 system of international EEG electrode placement, with CZ serving as the return electrode, which did not generate stimulation pulses.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dimensional Anhedonia Rating Scale (DARS)
기간: 12 week
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The Dimensional Anhedonia Rating Scale (DARS) assesses the degree of anhedonia in patients.
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12 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hamilton Depression Scale,HAMD -17
기간: 12 week
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The severity of a patient's depressive symptoms is assessed using the Hamilton Depression Scale (HAMD)-17.
This scale consists of 17 items that comprehensively evaluate a patient's depressive symptoms; the higher the score, the more severe the depressive symptoms.
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12 week
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- tACS-MDD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .