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기억력 향상을 위한 자극 (STIM)

2026년 6월 29일 업데이트: Benjamin Hampstead, PhD, University of Michigan

경도 인지 장애의 치료로 고화질 경두개 직류 자극(HD-tDCS) 테스트

이 연구는 경도 인지 장애(MCI) 및 알츠하이머형 치매(DAT)가 있는 개인의 치료를 위한 비침습적 뇌 자극 형태의 다양한 용량의 효과를 테스트할 것입니다.

연구 개요

상세 설명

이 연구는 경도 인지 장애(MCI) 및 알츠하이머형 치매(DAT)가 있는 사람들의 뇌 기능에 대한 약한 전기 자극의 영향에 대한 중요한 정보를 배우기 위해 수행되고 있습니다. 이 발견은 기억력과 사고 능력을 향상시키기 위해 "얼마나 많은" 자극이 필요한지, 그것이 뇌 기능에 어떤 영향을 미치는지, 누가 가장 혜택을 받을 것인지를 결정하는 데 도움이 될 것입니다. 궁극적으로 이 정보는 알츠하이머병의 다양한 단계에 있는 사람들을 위한 치료 노력을 안내할 수 있습니다. 이 연구는 뇌 영상을 사용하여 이러한 치료가 참가자가 정보를 배우고 기억하는 방식을 변경하는지 여부를 확인합니다. 기능적 자기 공명 영상(fMRI) 및 양전자 방출 단층 촬영(PET) 스캔이 사용됩니다. 이 연구는 또한 인지 테스트와 설문지를 사용하여 치료로 인해 참가자의 기억력(및 관련 능력)이 변하는지 여부를 조사할 것입니다. 이 연구는 MCI 또는 DAT 진단을 받은 참가자를 등록합니다. 참가자가 University of Michigan Memory and Aging Project(UM-MAP; HUM00000382)에 공동 등록될 것으로 예상되지만 필수는 아닙니다.

연구 유형

중재적

등록 (실제)

233

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Michigan
      • Ann Arbor, Michigan, 미국, 48105
        • University of Michigan

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

55년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  1. 경도인지장애(MCI) 또는 알츠하이머형 치매(DAT) 진단
  2. MRI와 호환되어야 하며 고화질 경두개 직류 자극에도 적용되는 기준(HD-tDCS, 예: 상체 또는 머리에 금속 또는 전자 이식 부재)
  3. 연구 등록 전 최소 4주 동안 관련 약물에 안정적임

제외 기준:

  1. 특정 신경계 질환
  2. 특정 정신 질환
  3. 심한 감각 장애

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
가짜 비교기: 가짜 자극
5~30회 세션 동안 30분 동안 HD-tDCS 치료의 가짜(위약) 용량.
참가자는 5~30회 세션 동안 30분 동안 가짜(위약) HD-tDCS를 받게 됩니다.
실험적: 1mA 용량 자극
5~30회 세션 동안 30분 동안 1milliAmp 용량의 HD-tDCS 치료.
참가자는 5~30회 세션 동안 30분 동안 1mA에서 HD-tDCS를 받게 됩니다.
실험적: 2mA 용량 자극
5~30회 세션 동안 30분 동안 2milliAmp 용량의 HD-tDCS 치료.
참가자는 5~30회 세션 동안 30분 동안 2mA에서 HD-tDCS를 받게 됩니다.
실험적: 3mA 용량 자극
5~30회 세션 동안 30분 동안 3milliAmp 용량의 HD-tDCS 치료.
참가자는 5~30회 세션 동안 30분 동안 3mA에서 HD-tDCS를 받게 됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Lateral Temporal Cortex Connectivity
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Primary outcome focuses on default mode network (DMN) between-network functional connectivity because the lateral temporal cortex is a core component of the DMN. Between-network functional connectivity is estimated from fMRI data as strength of temporal coupling between the DMN and other high-level (association) brain networks. For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) computed between DMN regions and other regions of the association cortex defined using standard functional atlas. Higher values reflect stronger functional connectivity between DMN and other regions. A Z-score's range is infinite. Expected value is between -3 to 3. Analyses conducted separately for amyloid negative (A-) and amyloid positive (A+) participants. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

2차 결과 측정

결과 측정
측정값 설명
기간
Self-Report of Contentment With Memory
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The Multifactorial Memory Questionnaire (MMQ) consists of three scales measuring separate aspects of metamemory. Items are rated on a 5-point Likert scale (0-4) based on the test taker's experiences over the previous two weeks.

MMQ-Satisfaction (formerly called MMQ-Contentment) scale measures satisfaction, concern, and overall appraisal of one's own memory. Each of 18 statements is rated based on degree of agreement. The score range is 0 to 72, with higher scores indicating a higher degree of satisfaction.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Self-Report of Memory Mistakes
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Multifactorial Memory Questionnaire (MMQ) Ability Score - This scale measures self-perception of everyday memory ability. Respondents rate how often they experienced each of 20 common memory mistakes over the previous two weeks. The score range is 0 to 80, with higher scores indicating better self-reported memory ability.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Self-Report of Memory Strategies Used
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Multifactorial Memory Questionnaire (MMQ) Strategies Score - This scale measures the use of practical memory strategies and aids in day-to-day life. Respondents rate how often they used each of 19 memory strategies over the previous two weeks. The score range is 0 to 76, with higher scores indicating greater use of memory strategies.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Memory Functioning
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition. The delayed memory section is a measure of delayed recall and recognition for verbal and visual information. It includes the subtests List Recall, List Recognition, Story Memory, and Figure Recall. Low scores on this index indicate difficulties with recognition and retrieval of information from long-term memory stores This index is composed of both auditory and visual measures; therefore, a severe deficit in language, auditory processing, or visual functioning may impact one of the measures more than the other. Analysis included the sum of the raw scores for each of the delayed memory subtests, with possible scores ranging from 0 to 62. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Overall Fluid Cognitive Abilities
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Cognitive function was determined using the NIH Toolbox-Cognition Battery computerized tests, specifically the Fluid composite score. It is derived by averaging the subtests in the Fluid domain to achieve an overall standard score. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Working Memory Effects of HD-tDCS Across Treatment Sessions
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The n-back test is a working memory task where participants identify stimulus that matches stimulus experienced "n" steps back. Participants performed a 2-back test, in which they were asked to remember and press a button when shown a stimulus that appeared 2 steps before the current one (e.g. square, circle, square).

The number of correct and incorrect identifications are normalized (z-score). Total score is the z-score of correct button presses minus the z-score of incorrect button presses. A higher score (d') reflects better working memory performance. Possible scores range from -4.85 to 4.85. Positive change (increase) in 2-back score across treatment sessions indicates improvement in working memory performance. Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y=n-back score.

Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Memory Accuracy Effects of HD-tDCS Across Treatment Sessions
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Paired Associates task is a verbal memory task that asks participants to learn a list of word pairs. After a delay, participants are shown correct and mismatched word pairs one at a time and asked to identify if the displayed word pair was from the list they were asked to learn or not.

Total accuracy is a proportion (total correct responses divided by total trials completed) ranging from 0 to 1 that measures the accuracy of a participant's responses to both correct and mismatched word pairs. Higher scores indicate better verbal memory performance, and positive changes over time indicate an improvement in verbal memory performance, measured after baseline (Session 1) and every intervention session (Sessions 2-5)

Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y= total accuracy.

Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Memory Sensitivity Effects of HD-tDCS Across Daily Sessions
기간: Baseline
Verbal memory performance for computerized Paired Associates task, summarized with a computational model (linear ballistic accumulator decision model). The model uses each participant's accuracy and reaction times across trials to estimate how efficiently they accumulate information to distinguish previously studied (target) word pairs from new (lure) pairs. Reported outcome is the average memory sensitivity score at baseline, expressed as unitless model values (scores on a scale) where higher scores indicate better discrimination, scores near zero indicate chance-level performance, and negative scores (if present) indicate performance worse than chance.
Baseline
Tolerability of HD-tDCS
기간: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
Tolerability was assessed using the HD-tDCS Safety Questionnaire, an 11-item symptom checklist. The questionnaire assesses the presence (yes/no) of 10 specific self-reported symptoms (Itching, Burning, Tingling, Scalp Pain, Trouble Concentrating, Sleep problems, Headache, Mood Change, Neck Pain, and Other symptoms) and 1 oberserved symptom, Skin Redness. Skin Redness was excluded from this analysis as it is not related to the participant's perception of tolerability. The total score (symptom burden) was calculated by summing the number of symptoms present across the 10 items for each session. Score range: 0 to 10 symptoms, where 0 = no symptoms present and 10 = all symptoms present. Higher scores indicate worse tolerability (more symptoms experienced). Values represent the mean number of symptoms per session, calculated by averaging symptom burden scores across all post-stimulation assessments within each treatment group.
Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments
Effectiveness of Blinding of HD-tDCS
기간: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
Participant's perception of treatment assignment assessed after each stimulation session using a 3-category ordinal scale. Participants guessed whether they received: (0) Sham stimulation, (1) Don't Know, or (2) Active stimulation. The scale is ordinal with Sham < Don't Know < Active. Effective blinding is indicated by no significant difference in the distribution of perceived assignment between active and sham groups (i.e., participants in active groups cannot reliably distinguish their treatment from sham). Higher proportional odds ratios would indicate active group participants were more likely to guess "active"; lower ratios would indicate sham participants were more likely to guess "active" (paradoxical pattern suggesting convincing sham condition).
Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)
Change in Default Mode Network Connectivity
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The outcome focuses on default mode network (DMN) within-network functional connectivity. Within-network functional connectivity is estimated from fMRI data as strength of temporal coupling within DMN regions (nodes). For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) was computed between DMN regions defined using a standard functional atlas. Higher values reflect stronger functional connectivity within DMN. A Z-score's range is infinite. Expected value is around -3 to 3. Analyses are conducted separately for amyloid negative (A-) and amyloid positive (A+) participants.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Cumulative Cognitive Change Across Daily Consecutive Sessions
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions.
Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).
Change in Global Cognition
기간: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. Data was analyzed using the sum of the subtest raw scores, which is an indicator of the general cognitive functioning of the examinee. Low scores suggest general cognitive impairment even when some individual subtest scores may be within normal limits. Individuals with low scores on this measure exhibit problems with attention, memory, language, and construction skills. Possible scores range from 0 to 321.

Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

기타 결과 측정

결과 측정
측정값 설명
기간
억제 능력의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
NIH Toolbox Flanker Inhibitory Control 및 Attention Test Score의 변경을 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
개념화 능력의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
NIH Toolbox Dimensional Change Card Sort Test Score의 변화를 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
그림 시퀀스 메모리의 변경
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
NIH Toolbox Picture Sequence Memory Test Score의 변화를 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
작업 기억 능력의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
NIH Toolbox List Sorting Working Memory Test Score의 변경을 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
처리 속도의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
NIH Toolbox 패턴 비교 처리 속도 테스트 점수의 변경을 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
시공간 기능의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
RBANS Visuospatial Index 점수 변화를 통해 측정
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
언어 기능의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
RBANS Language Index 점수의 변화를 통해 측정
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
관심의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
RBANS Attention Index 점수의 변화를 통해 측정
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
기억 기능의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
RBANS Immediate Memory Index 점수의 변화를 통해 측정
기준선 및 개입 후(tDCS 세션 5 및 30 이후)
인지 기능의 변화
기간: 기준선 및 개입 후(tDCS 세션 5 및 30 이후)
RBANS 하위 테스트 점수의 변화를 통해 측정하려는 선험적 의도
기준선 및 개입 후(tDCS 세션 5 및 30 이후)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Benjamin Hampstead, PhD, Associate Professor

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 (실제)

2019년 4월 1일

기본 완료 (실제)

2024년 12월 6일

연구 완료 (실제)

2024년 12월 19일

연구 등록 날짜

최초 제출

2019년 3월 11일

QC 기준을 충족하는 최초 제출

2019년 3월 13일

처음 게시됨 (실제)

2019년 3월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 29일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HUM00146180
  • 1R01AG058724 (미국 NIH 보조금/계약)

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

미국에서 제조되어 미국에서 수출되는 제품

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. .

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