Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (MASH)
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|ClinicalTrials.gov Identifier: NCT02864940|
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ruptured Aneurysm Memory Deficits Subarachnoid Hemorrhage||Device: Lumosity Device: Crossword puzzle||Not Applicable|
In this prospective randomized, control clinical trial subjects have a self-reported disabling memory deficit within the first two years of their ruptured cerebral aneurysm. Subjects will be recruited in the neurosurgery clinic setting, via email and phone screen, through social media and phone screen, or during a monthly support group for the patient population in question.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 15, 2018|
|Actual Study Completion Date :||August 28, 2018|
Experimental: Intervention Arm
Using the cognitive exercises on Lumosity for 10 weeks
A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
Active Comparator: Control Arm
Using online crossword puzzles for 10 weeks.
Device: 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.
- Cognitive and Emotional complaints [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]The change in scoring from baseline to 10 weeks for the checklist for cognitive and emotional consequences following stroke (CLCE-24) questionnaire will be evaluated.
- Working memory [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]The change in scoring from baseline to 10 weeks for the working memory test (which assesses the different areas of working memory including attention, executive function and working memory will be evaluated.
- Activity of Daily Living (ADL) [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]The change in scoring from baseline to 10 weeks for the ADL test (which assesses standard areas of daily living to determine the number as well as the severity of the problem) will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864940
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|