집중적인 컴퓨터 인지 훈련의 영향 (CCT)
2026년 9월 28일 업데이트: Kirk Daffner, MD, Brigham and Women's Hospital
전산화된 인지 훈련: 후천성 뇌손상에서 인지 향상을 예측하는 요인의 특성화
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
연구 개요
상세 설명
To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.
The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.
연구 유형
중재적
등록 (추정된)
30
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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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's 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
25년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patient of the Mass General Brigham Health System with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (ABI) sustained at least 12 months prior to study contact.
- Ages 25-65 years old
- Proficiency in English
- Willing and able to complete all study-related activities for 12 months, including travel to Brigham and Women's Hospital (Boston) for four in-person assessment visits and two serum and saliva sample collections.
- Access to a computer with webcam and stable internet.
- A reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points.
Exclusion Criteria:
- History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
- High likelihood of an underlying progressive neurodegenerative disorder.
- Evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the Mini-Mental Status Examination (MMSE) (Tombaugh & McIntyre, 1992).
- Patient Health Questionnaire (PHQ)-9 (Kroenke et al., 2010) Score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction).
- Active psychotic symptoms.
- Severe sensory losses such that participants would unlikely be able to participate in the study training, even with substantial accommodations (self-report of extreme difficulty reading ordinary newspaper print or a performance-tested corrected vision test score of worse than 20/30).
- Communication difficulties that prevent the participant from effectively participating in this highly interactive study protocol (based on interviewer's rating of a person's ability to be understood and to understand others).
- Current participation in a pharmacological, or other interventional research trial.
- Life expectancy of < 2 years.
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Computerized Cognitive Training
See section of intervention/treatment for additional information. |
Participants will log into ABI Wellness Platform five days per week (M-T-W-Th-F) and train using the Symbol Relations module for 45 to 60 minutes. Every other week, participants will meet with their training facilitator via zoom to review training progress and troubleshoot any training-related questions. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in cognitive outcome measures
기간: 6 months
|
We will use age-corrected standard scores of the NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, and individual scores on RAVLT, Verbal Fluency, and Trailmaking Task as cognitive outcome measures. |
6 months
|
|
Changes in BDNF Levels in blood and saliva
기간: 6 months
|
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits. |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-report exercise and physical activity
기간: 6 months
|
Physical Activity Scale for the Elderly (questionnaire). Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity. |
6 months
|
|
Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)
기간: 6 months
|
1) Measured in response to verbal and visual working memory tasks |
6 months
|
|
Intervention-related changes in resting state fMRI
기간: 6 months
|
A group ICA analysis procedure will be applied to pre- and post-intervention rs-fMRI BOLD signal activity. Correlations will be explored between fMRI parameters, cognitive, and training data (e.g NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, Crystallized Composite, CCT engagement and progress). |
6 months
|
|
Quality of life self-report
기간: 6 months
|
Flanagan Quality of Life Scale (questionnaire). Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life. |
6 months
|
|
Sleep
기간: 6 months
|
Medical Outcomes Study Sleep Scale (questionnaire) Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems. |
6 months
|
|
Anxiety
기간: 6 months
|
Generalized Anxiety Disorder 7 Item Scale (questionnaire) Likert scale measuring severity of anxiety. 0-21 with greater values representing more severe anxiety. |
6 months
|
|
Depression
기간: 6 months
|
Patient Health Questionnaire Depression Scale (questionnaire) Likert scale measuring the severity of depression. 0-24 with higher scores representing more severe depression. |
6 months
|
|
Self-report on impact of fatigue
기간: 6 months
|
Modified Fatigue Impact Scale Likert scale on the impact of fatigue on one's physical, cognitive, and psychosocial activity. 0-84 with higher scores indicating a greater impact of fatigue on a person's activities. |
6 months
|
|
Feelings about cognitive/thinking skills
기간: 6 months
|
Cognitive Self- Efficacy Questionnaire Likert scale on feelings people have about their cognition/thinking skills. 0-72 with a higher score indicating more positive feelings regarding the efficacy of ones cognitive/thinking abilities. |
6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Kim C Willment, PhD, Brigham and Women's Hospital
- 수석 연구원: Kirk R Daffner, MD, Brigham and Women's Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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유용한 링크
- <p>Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review</p>
- <p>Tracking early decline in cognitive function in older individuals at risk for Alzheimer's disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument</p>
- <p>Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia</p>
- <p>Resting state fMRI: a personal history</p>
- <p>Opportunities and limitations of intrinsic functional connectivity MRI</p>
- <p>The Flanagan Quality Of Life Scale: evidence of construct validity</p>
- <p>Resting-State Functional Connectivity: Signal Origins and Analytic Methods</p>
- <p>Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study</p>
- <p>Mechanisms Underlying Age- and Performance-related Differences in Working Memory</p>
- <p>National Institutes of Health Toolbox Cognition Battery</p>
- <p>Neuropsychological functioning during the year following severe traumatic brain injury</p>
- <p>The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services</p>
- <p>That which doesn't kill us can make us stronger (and more satisfied with life): the contribution of personal and social changes to well-being after acquired brain injury</p>
- <p>Psychosocial functioning during the year following severe traumatic brain injury</p>
- <p>Group dynamics in the rehabilitation of hemiplegic patients</p>
- <p>Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study</p>
- <p>BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults</p>
- <p>The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review</p>
- <p>Modified Fatigue Impact Scale</p>
- <p>Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury</p>
- <p>Resting-state brain networks: literature review and clinical applications</p>
- <p>Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial</p>
- <p>The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue</p>
- <p>The ACTIVE study: study overview and major findings</p>
- <p>The mini-mental state examination: a comprehensive review</p>
- <p>A comparison of the cost-effectiveness of two types of occupational therapy services</p>
- <p>The measurement of participant-reported memory across diverse populations and settings: a systematic review and meta-analysis of the Multifactorial Memory Questionnaire</p>
- <p>Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances</p>
- <p>Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults</p>
- <p>Rey Auditory-Verbal Learning Test: structure analysis</p>
- <p>Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression</p>
- <p>Acquired brain injury: combining social psychological and neuropsychological perspectives</p>
- <p>The Physical Activity Scale for the Elderly (PASE): development and evaluation</p>
- <p>Group therapy utilization in inpatient spinal cord injury rehabilitation</p>
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)
2023년 10월 1일
기본 완료 (실제)
2025년 12월 5일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2023년 10월 30일
QC 기준을 충족하는 최초 제출
2023년 11월 8일
처음 게시됨 (실제)
2023년 11월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 28일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2022P003401
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. .