Online Memory Intervention for Individuals with Traumatic Brain Injury

Официальное название

Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial

Обзор

This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.

Подробное описание

The memory impairments associated with moderate to severe traumatic brain injury can be debilitating to younger and older adults, and can prevent a person's return to work, school and social life. The "hippocampus" is a ubiquitously compromised memory brain structure in moderate-severe TBI. Unfortunately, not only does the hippocampus sustain the damage at the time of injury, but researchers have identified that it shows continued atrophy in the months and years following injury. The investigators has developed a promising behavioural intervention for arresting this shrinkage, enhancing the integrity of the hippocampus - and improving memory function. It entails engagement in novel, continuous and challenging allocentric spatial navigation, that is, learning new routes of cities, and making a map in one's head of those routes for 1 hour/day, 5 days per week for a period of 16 weeks. N=87 participants will be randomized to either the intervention group or an active control group that will watch 3 TedTalk videos per day, 5 days a week for the same duration. An MRI scan and cognitive measures focusing on memory and spatial navigation will be conducted before and after participation.

Вмешательства

• Поведенческое Spatial Navigation Intervention
  The 16-week intervention is completed daily, 5 days/week, remotely from home on a designated study website. Each week participants learn a new city through navigation tasks which increase in difficulty day-to-day and have a total of 4 levels of difficulty, with the goal of being able to independently navigate the city by the end of the week via Google Street View. Participants complete end-of-day multiple-choice tasks, testing what they learned with 3 types of allocentric questions: 1) predictin
• Поведенческое Educational Videos
  The 16-week active control, remote video intervention is completed daily, 5 days a week by participants on a designated website. Participants placed in the active control group are trained on educational topics by watching videos of Ted Talks, to control for the effects of generalized environmental enrichment of the same dose as targeted navigation training. For each day of training, participants are asked to select between an option of 2 possible videos, watching a total of three videos per day

Первичные конечные точки

• Imaging [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance, [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance. [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Path Integration Task (Medium transfer) performance. [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Memory Image Completion Task (MIC) (Far transfer) performance [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Mnemonic Similarity Test (MST) (Far transfer) performance [Срок оценки: Baseline and 1 week post-intervention.]
• Navigational abilities (near-transfer) [Срок оценки: Measured throughout the completion of the 16-week spatial navigation intervention.]
• Change in Navigational Strategies Questionnaire score (medium transfer) [Срок оценки: Baseline and 1 week post-intervention.]
• Change in Santa Barbara Sense of Direction Scale score (medium transfer) [Срок оценки: Baseline and 1-week post-intervention.]
• Change in Everyday Memory Questionnaire score (far transfer) [Срок оценки: Baseline and 1 week post-intervention.]

Вторичные конечные точки (5)

• Feasibility: Recruitment rate [Срок оценки: Collected during recruitment]
• Feasibility: Retention rate [Срок оценки: Collected during recruitment and 1 week post-follow-up]
• Feasibility: Compliance rate [Срок оценки: Collected during each of the 80 session (5 sessions/week, 16 weeks)]
• Feasibility: semi-structured interview [Срок оценки: 1 week post-intervention]
• Change in How Much Is Too Much scale score [Срок оценки: At the end of each of the 16 weeks]

Критерии участия

Критерии включения

• acute care diagnosis of m-sTBI
• PTA of 24 hours or more and/or lowest GCS <13
• positive CT or MRI; (4) between 18 to 55 years of age
• fluency in English; (6) competency to provide informed consent or availability of a legal decision maker
• basic computer skills (use of internet/email, mouse and arrow keys)
• functional use of at least one upper extremity for computer use
• resident of Greater Toronto Area (to facilitate access to the MRI).

Критерии исключения

• neurological disorder other than TBI (e.g., dementia, stroke)
• diagnosis of a neurodevelopmental disorder
• TBI sustained before age 18
• systemic comorbidities (e.g., lupus, diabetes)
• current diagnosis of aphasia
• presence of metal inside the body (e.g., surgical clips, pacemaker) leading to ineligibility for an MRI.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Toronto Rehabilitation Institute — Toronto

Публикации

• Corrow JC, Corrow SL, Lee E, Pancaroglu R, Burles F, Duchaine B, Iaria G, Barton JJS. Getting lost: Topographic skills in acquired and developmental prosopagnosia. Cortex. 2016 Mar;76:89-103. doi: 10.1016/j.cortex.2016.01.003. Epub 2016 Jan 22. PMID 26874939
• Wiener JM, Carroll D, Moeller S, Bibi I, Ivanova D, Allen P, Wolbers T. A novel virtual-reality-based route-learning test suite: Assessing the effects of cognitive aging on navigation. Behav Res Methods. 2020 Apr;52(2):630-640. doi: 10.3758/s13428-019-01264-8. PMID 31236900
• Persson J, Herlitz A, Engman J, Morell A, Sjolie D, Wikstrom J, Soderlund H. Remembering our origin: gender differences in spatial memory are reflected in gender differences in hippocampal lateralization. Behav Brain Res. 2013 Nov 1;256:219-28. doi: 10.1016/j.bbr.2013.07.050. Epub 2013 Aug 9. PMID 23938766
• Vieweg P, Riemer M, Berron D, Wolbers T. Memory Image Completion: Establishing a task to behaviorally assess pattern completion in humans. Hippocampus. 2019 Apr;29(4):340-351. doi: 10.1002/hipo.23030. Epub 2018 Nov 23. PMID 30246900
• Vieweg P, Stangl M, Howard LR, Wolbers T. Changes in pattern completion--a key mechanism to explain age-related recognition memory deficits? Cortex. 2015 Mar;64:343-51. doi: 10.1016/j.cortex.2014.12.007. Epub 2014 Dec 29. PMID 25597525
• Stark SM, Yassa MA, Lacy JW, Stark CE. A task to assess behavioral pattern separation (BPS) in humans: Data from healthy aging and mild cognitive impairment. Neuropsychologia. 2013 Oct;51(12):2442-9. doi: 10.1016/j.neuropsychologia.2012.12.014. Epub 2013 Jan 9. PMID 23313292
• Sunderland, A., Harris, J. E., & Baddeley, A. D. (1983). Do laboratory tests predict everyday memory? A neuropsychological study. Journal of verbal learning and verbal behavior, 22(3), 341-357.
• Wiener, J., & Wolbers, T. (2018). Route Learning & Navigation Test Battery. Retrieved from osf.io/mx52y

Идентификаторы

NCT: NCT04331392 · 2017-ABI-INFRA-1035

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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