Auswirkungen des intensiven computergestützten kognitiven Trainings (CCT)
28. September 2026 aktualisiert von: Kirk Daffner, MD, Brigham and Women's Hospital
Computergestütztes kognitives Training: Charakterisierung von Faktoren, die eine kognitive Verbesserung bei erworbenen Hirnverletzungen vorhersagen
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Women's Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
25 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in cognitive outcome measures
Zeitfenster: 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
Zeitfenster: 6 months
|
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits. |
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-report exercise and physical activity
Zeitfenster: 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)
Zeitfenster: 6 months
|
1) Measured in response to verbal and visual working memory tasks |
6 months
|
|
Intervention-related changes in resting state fMRI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kim C Willment, PhD, Brigham and Women's Hospital
- Hauptermittler: Kirk R Daffner, MD, Brigham and Women's Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
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- Billig AR, Feng NC, Behforuzi H, McFeeley BM, Nicastri CM, Daffner KR. Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia. Cortex. 2020 Dec;133:277-294. doi: 10.1016/j.cortex.2020.09.005. Epub 2020 Sep 24.
- Biswal BB. Resting state fMRI: a personal history. Neuroimage. 2012 Aug 15;62(2):938-44. doi: 10.1016/j.neuroimage.2012.01.090. Epub 2012 Jan 24.
- Buckner RL, Krienen FM, Yeo BT. Opportunities and limitations of intrinsic functional connectivity MRI. Nat Neurosci. 2013 Jul;16(7):832-7. doi: 10.1038/nn.3423. Epub 2013 Jun 25.
- Burckhardt CS, Anderson KL, Archenholtz B, Hagg O. The Flanagan Quality Of Life Scale: evidence of construct validity. Health Qual Life Outcomes. 2003 Oct 23;1:59. doi: 10.1186/1477-7525-1-59.
- Chen K, Azeez A, Chen DY, Biswal BB. Resting-State Functional Connectivity: Signal Origins and Analytic Methods. Neuroimaging Clin N Am. 2020 Feb;30(1):15-23. doi: 10.1016/j.nic.2019.09.012.
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- Holloway M, Tasker R. The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services. Journal of Long-term Care. 2019, p.99-110
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- Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022.
- Retan R, Wolfson D. The Halstead-Reitan neuropsychological test battery: Theory and clinical interpretation. Neuropsychology Press. 1985.
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- Sevick et al. Alterations in Resting State Functional Connectivity in Patients with Traumatic Brain Injury Following a 3-month Pilot Cognitive Intervention Program. Poster Presented at: UBC Department of Psychiatry 2020 Virtual Research Day. 2020.
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- Tulsky DS, Kisala PA. Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances. Arch Phys Med Rehabil. 2022 Feb;103(2):185-190. doi: 10.1016/j.apmr.2021.10.006. Epub 2021 Oct 28.
- Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.
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Nützliche Links
- <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>
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2023
Primärer Abschluss (Tatsächlich)
5. Dezember 2025
Studienabschluss (Geschätzt)
1. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
30. Oktober 2023
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. November 2023
Zuerst gepostet (Tatsächlich)
14. November 2023
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Oktober 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2022P003401
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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