- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07560904
Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory (DEEPBRAIN)
A study investigating the effects of non-invasive electrical stimulation of deep brain structures on working memory, attention, and executive functions involved in everyday activities. Currently, there is no effective treatment for impairments in these functions. The study will evaluate the effects of non-invasive electrical stimulation in both healthy older adults and individuals with mild impairment of these functions.
The study combines magnetic resonance imaging (MRI) with non-invasive brain stimulation targeting deep brain structures. Its aim is to improve understanding of the neural mechanisms underlying these cognitive functions and their impairments, as well as to explore the mechanisms of non-invasive brain stimulation for potential future therapeutic applications.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Monika Pupíková
- 전화번호: +420549498818
- 이메일: monika.pupikova@ceitec.muni.cz
연구 장소
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Brno, 체코, 612 00
- 모병
- CEITEC Masaryk University
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연락하다:
- Monika Pupíková
- 전화번호: +420549498818
- 이메일: monika.pupikova@ceitec.muni.cz
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연락하다:
- 이메일: pupikovam@gmail.com
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부수사관:
- Monika Pupíková
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- normal cognitive performance as assessed by a cognitive screening for healthy subjects
- possible or probable MCI-LB or with PD-MCI, collectively called MCI-LBD, described as: presence of PD , and level II criteria for MCI (i.e. based on comprehensive neuropsychological examination), or the level II criteria for MCI , and at least two of four core DLB features including parkinsonism, visual hallucinations, attention/cognitive function fluctuation, and REM sleep behavioral disorder, or at least 1 core clinical feature and 1 indicative biomarker (probable MCI-LB).
Exclusion Criteria:
- Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 20 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (20 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
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Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (20 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
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실험적: 60 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (60 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
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Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (60 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
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가짜 비교기: Sham striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with no low-frequency offset.
The stimulation will be applied only shortly and turned off after ramp-up and ramp-down period.
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A high-frequency tES without low-frequency offset.
It will consist of two oscillatory high-frequency currents without any frequency shifts, which induces similar skin sensations as deep-tES and will be applied just for a ramp-up/ramp-down phases at the beginning of the stimulation and afterwards will be switched off.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
기간: During intervention ( approximately 10 minutes)
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During intervention ( approximately 10 minutes)
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The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
기간: During intervention ( approximately 10 minutes)
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During intervention ( approximately 10 minutes)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Working memory performance - Reaction times
기간: During intervention (approx 10 minutes)
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Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.
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During intervention (approx 10 minutes)
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Working memory parformance - Accuracy
기간: During intervention ( approximately 10 minutes)
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Accuracy (measured as D-prime) of an N-back task between the real and sham stimulation condition in a cross-over design.
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During intervention ( approximately 10 minutes)
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공동 작업자 및 조사자
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 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. .