Impacto del entrenamiento cognitivo computarizado intensivo (CCT)
28 de septiembre de 2026 actualizado por: Kirk Daffner, MD, Brigham and Women's Hospital
Entrenamiento cognitivo computarizado: caracterización de factores que predicen la mejora cognitiva en la lesión cerebral adquirida
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
Descripción general del estudio
Estado
Activo, no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
25 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in cognitive outcome measures
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits. |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-report exercise and physical activity
Periodo de tiempo: 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)
Periodo de tiempo: 6 months
|
1) Measured in response to verbal and visual working memory tasks |
6 months
|
|
Intervention-related changes in resting state fMRI
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kim C Willment, PhD, Brigham and Women's Hospital
- Investigador principal: Kirk R Daffner, MD, Brigham and Women's Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
- Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7.
- Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
- 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.
- Porter S, Torres IJ, Panenka W, Rajwani Z, Fawcett D, Hyder A, Virji-Babul N. Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury. Heliyon. 2017 Aug 4;3(8):e00373. doi: 10.1016/j.heliyon.2017.e00373. eCollection 2017 Aug.
- Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992 Sep;40(9):922-35. doi: 10.1111/j.1532-5415.1992.tb01992.x.
- Norman A, Curro V, Holloway M, Percuklievska N, Ferrario H. Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review. Disabil Rehabil. 2023 Feb;45(4):739-751. doi: 10.1080/09638288.2022.2043465. Epub 2022 Mar 4.
- 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.
- Coulter CL, Weber JM, Scarvell JM. Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study. Arch Phys Med Rehabil. 2009 Oct;90(10):1727-33. doi: 10.1016/j.apmr.2009.04.019.
- Daffner KR, Chong H, Sun X, Tarbi EC, Riis JL, McGinnis SM, Holcomb PJ. Mechanisms underlying age- and performance-related differences in working memory. J Cogn Neurosci. 2011 Jun;23(6):1298-314. doi: 10.1162/jocn.2010.21540. Epub 2010 Jul 9.
- Kersel DA, Marsh NV, Havill JH, Sleigh JW. Neuropsychological functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Apr;15(4):283-96. doi: 10.1080/02699050010005887.
- Denboer JW, Nicholls C, Corte C, Chestnut K. National Institutes of Health Toolbox Cognition Battery. Archives of Clinical Neuropsychology. 2014; 29(7): 692-694
- Hays RD, Stewart AL. Measuring functioning and well-being: The Medical Outcomes Study Approach. Duke University Press. 1992.
- 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
- Ivnik RJ, Malec JF, Smith GE, Tangalos EG, Petersen, RC. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE Token, WRAT-R Reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist. 1996; 10(3): 262-278.
- Jones JM, Haslam SA, Jetten J, Williams WH, Morris R, Saroyan S. 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. Psychol Health. 2011 Mar;26(3):353-69. doi: 10.1080/08870440903440699.
- Kersel DA, Marsh NV, Havill JH, Sleigh JW. Psychosocial functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Aug;15(8):683-96. doi: 10.1080/02699050010013662.
- Kurasik S. Group dynamics in the rehabilitation of hemiplegic patients. J Am Geriatr Soc. 1967 Sep;15(9):852-5. doi: 10.1111/j.1532-5415.1967.tb02443.x. No abstract available.
- Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756.
- Levin C, Chisholm D.
- Lezak MD, Howieson DB, Bigler ED, & Tranel D. Neuropsychological assessment, 5th ed. APA PsychNet. 2012.
- 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.
- Rosazza C, Minati L. Resting-state brain networks: literature review and clinical applications. Neurol Sci. 2011 Oct;32(5):773-85. doi: 10.1007/s10072-011-0636-y. Epub 2011 Jun 11.
- Schulenberg SE, Yutrzenka BA, Gohm CL. The Computer Aversion, Attitudes, and Familiarity Index (CAAFI): A Measure for the Study of Computer-Related Constructs. Journal of Educational Computing Research. 2006; 34(2): 129-146.
- 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.
- Tennstedt SL, Unverzagt FW. The ACTIVE study: study overview and major findings. J Aging Health. 2013 Dec;25(8 Suppl):3S-20S. doi: 10.1177/0898264313518133. No abstract available.
- Trahey PJ. A comparison of the cost-effectiveness of two types of occupational therapy services. Am J Occup Ther. 1991 May;45(5):397-400. doi: 10.5014/ajot.45.5.397.
- Troyer AK, Leach L, Vandermorris S, Rich JB. The measurement of participant-reported memory across diverse populations and settings: a systematic review and meta-analysis of the Multifactorial Memory Questionnaire. Memory. 2019 Aug;27(7):931-942. doi: 10.1080/09658211.2019.1608255. Epub 2019 Apr 25.
- 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.
- Vakil E, Blachstein H. Rey Auditory-Verbal Learning Test: structure analysis. J Clin Psychol. 1993 Nov;49(6):883-90. doi: 10.1002/1097-4679(199311)49:63.0.co;2-6.
- Vos T, Corry J, Haby MM, Carter R, Andrews G. Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression. Aust N Z J Psychiatry. 2005 Aug;39(8):683-92. doi: 10.1080/j.1440-1614.2005.01652.x.
- Walsh RS, Fortune DG, Gallagher S, Muldoon OT. Acquired brain injury: combining social psychological and neuropsychological perspectives. Health Psychol Rev. 2014;8(4):458-72. doi: 10.1080/17437199.2012.733914. Epub 2012 Oct 22.
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- Zanca JM, Dijkers MP, Hsieh CH, Heinemann AW, Horn SD, Smout RJ, Backus D. Group therapy utilization in inpatient spinal cord injury rehabilitation. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S145-53. doi: 10.1016/j.apmr.2012.11.049.
- Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375.
Enlaces Útiles
- <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>
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2023
Finalización primaria (Actual)
5 de diciembre de 2025
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
30 de octubre de 2023
Primero enviado que cumplió con los criterios de control de calidad
8 de noviembre de 2023
Publicado por primera vez (Actual)
14 de noviembre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2022P003401
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .