Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients
NCT ID: NCT02864940
Last Updated: 2023-04-10
Study Results
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View full resultsBasic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2016-06-30
2018-08-28
Brief Summary
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Detailed Description
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During the screening interview the inclusion and exclusion criteria are assessed and informed consent is obtained if needed.
Those who qualify for the study will undergo a baseline assessment involving Checklist for cognitive and emotional consequences following stroke (CLCE-24), Working memory questionnaire, Activity of Daily living Questionnaire, and a Lumosity Administered assessment.
After baseline assessments randomization will occur stratified according to duration since SAH \<12 or \>12 months, to either a treatment group, which will include online access to structure-oriented activities (Lumosity), or an active control group(online crossword puzzles).
Subjects in the intervention group will undergo twenty training sessions over 10 weeks involving cognitive games selected from Lumocity. Games will be customized using an automated algorithm supplied by Lumosity, to determine performance in the various targeted skills, which include: task switching, logical reasoning, quantitative reasoning, response inhibition, numerical calculation, working memory, face-name recall, selective attention, spatial recall, spatial orientations, planning, and divided attention. The recommended duration of interaction is 2 hours per week for 10 weeks.
The control group uses a computerized crossword puzzle. the puzzle is offered in three different puzzle sizes, levels of complexity, and font sizes. these puzzles do not provide progressive challenge to the user by either increased speed, visual field size, number of distractors, or degree of difficulty of target stimulus differentiation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
Using the cognitive exercises on Lumosity for 10 weeks
Lumosity
A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
Control Arm
Using online crossword puzzles for 10 weeks.
Crossword puzzle
This game offers a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also includes optional help features such as filling in an unknown letter or word.
Interventions
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Lumosity
A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
Crossword puzzle
This game offers a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also includes optional help features such as filling in an unknown letter or word.
Eligibility Criteria
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Inclusion Criteria
* Age 18 and older
* Those with a modified Rankin 0 or 1
* Baseline memory problem affecting daily life
* Home computer or tablet with internet access
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Lumos Labs, Inc.
INDUSTRY
Rush University Medical Center
OTHER
Responsible Party
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Michael Chen, M.D.
Associate Professor of Neurology, Neurosurgery and Radiology
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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References
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Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
Rinkel GJ, Algra A. Long-term outcomes of patients with aneurysmal subarachnoid haemorrhage. Lancet Neurol. 2011 Apr;10(4):349-56. doi: 10.1016/S1474-4422(11)70017-5.
Passier PE, Visser-Meily JM, van Zandvoort MJ, Post MW, Rinkel GJ, van Heugten C. Prevalence and determinants of cognitive complaints after aneurysmal subarachnoid hemorrhage. Cerebrovasc Dis. 2010;29(6):557-63. doi: 10.1159/000306642. Epub 2010 Apr 8.
Sheldon S, Macdonald RL, Schweizer TA. Free recall memory performance after aneurysmal subarachnoid hemorrhage. J Int Neuropsychol Soc. 2012 Mar;18(2):334-42. doi: 10.1017/S1355617711001780. Epub 2012 Feb 13.
Sheldon S, Macdonald RL, Cusimano M, Spears J, Schweizer TA. Long-term consequences of subarachnoid hemorrhage: examining working memory. J Neurol Sci. 2013 Sep 15;332(1-2):145-7. doi: 10.1016/j.jns.2013.06.021. Epub 2013 Jul 18.
Al-Khindi T, Macdonald RL, Schweizer TA. Decision-making deficits persist after aneurysmal subarachnoid hemorrhage. Neuropsychology. 2014 Jan;28(1):68-74. doi: 10.1037/neu0000003. Epub 2013 Sep 16.
Chen M, Mangubat E, Ouyang B. Patient-reported outcome measures for patients with cerebral aneurysms acquired via social media: data from a large nationwide sample. J Neurointerv Surg. 2016 Jan;8(1):42-6. doi: 10.1136/neurintsurg-2014-011492. Epub 2014 Dec 1.
Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
Westerberg H, Jacobaeus H, Hirvikoski T, Clevberger P, Ostensson ML, Bartfai A, Klingberg T. Computerized working memory training after stroke--a pilot study. Brain Inj. 2007 Jan;21(1):21-9. doi: 10.1080/02699050601148726.
Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8.
van Heugten C, Rasquin S, Winkens I, Beusmans G, Verhey F. Checklist for cognitive and emotional consequences following stroke (CLCE-24): development, usability and quality of the self-report version. Clin Neurol Neurosurg. 2007 Apr;109(3):257-62. doi: 10.1016/j.clineuro.2006.10.002. Epub 2006 Nov 28.
Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
Johnson N, Barion A, Rademaker A, Rehkemper G, Weintraub S. The Activities of Daily Living Questionnaire: a validation study in patients with dementia. Alzheimer Dis Assoc Disord. 2004 Oct-Dec;18(4):223-30.
Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults. PLoS One. 2013 May 1;8(5):e61624. doi: 10.1371/journal.pone.0061624. Print 2013.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MASH 14080402
Identifier Type: -
Identifier Source: org_study_id
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