MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)
Phase: NA
Conditions: Ruptured Aneurysm, Memory Deficits, Subarachnoid Hemorrhage
Sponsor: Rush University Medical Center

 
 
 
 
 
 
MASH Study (Memory training in Aneurysmal Subarachnoid Hemorrhage Patients) 
 
NCT02864940 
 
24 Jun 2015 
 
24 Jun 2015

Investigators:  Megan Konopka, Michael Chen, M.D.
Location:  Rush University Medical Center, Neurosurgery Department
Study Title:  MASH Study (Memory training in Aneurysmal Subarachnoid Hemorrhage 
Patients)
Hypothesis:  Periodic online cognitive exercises improve memory function in cognitively 
disabled aneurysmal subarachnoid hemorrhage patients
Background and Rationale: 
Ruptured cerebral aneurysms affect nearly 40,000 individuals annually in the United States 
and unlike other causes for stroke, have not decreased in incidence.  Its burden is of concern 
given that the peak age of rupture is 52.  As such, aneurysmal subarachnoid hemorrhage 
(SAH) is responsible for a disproportionately high burden of long-term disability among all 
stroke patients.  Furthermore, population-based survival rates have improved for these 
patients.  Therefore, among this growing number of survivors, are a growing number with 
no physical limitations yet burdened by substantial cognitive deficits that variably impair 
their quality of life.  Their outward physical appearance and neurologic examination can be 
deceiving with regards to their functional status.  
Cognitive deficits are a common challenge in patients with ruptured cerebral aneurysms.  At 
three months of follow up, nearly 95% of patients report at least one cognitive or emotional 
complaint that hampers everyday functioning[2].  The most frequently cited complaint 
involves memory, attention and mental slowness(2).  Specifically, this involves strategic and 
organizational processes, referred to as executive function(4).  Sheldon et al studied 24 SAH 
patients with matched controls and found SAH patients had greater difficulty with 
unorganized lists of items to remember as opposed to organized lists.  They postulated that 
this deficit was due to a disconnection between different cognitive processes that were 
needed to work together for demanding tasks, which was in essence, executive 
functioning(5).   Another described memory deficit specific to SAH was cognitive 
inflexibility, whereby there is difficulty shifting attention between tasks.   Executive 
functioning allows planning, suppression of automatic actions and monitoring behavior to 
adjust attention for different tasks (6). Without this ability, one is unable to move from one 
task to another and then return.  They become unable to move fluidly between tasks and 
often report that when forced to change tasks, they are unable to return to what they were 
previously doing. 
Anecdotally, in our practice, which specializes in the care of brain aneurysm patients, these 
concerns surface again and again.  It is precisely because of this pattern we observed while 
caring for patients with previously ruptured brain aneurysms that prompted us to look for 
solutions to address this seemingly unmet clinical need.  
These deficits are particularly insidious because they may be overlooked by the physician 
or family.  Nevertheless, when asked, patients report cognitive deficits to be one of their 
most disabling deficits (7)Oftentimes, these deficits can only be detected with 
neuropsychological testing, which may not be accessible or available to many patients.  
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Often patients who report these problems have a favorable recovery in the hospital and are 
discharged home and are largely able to care for themselves.  The primary deficit keeping 
them from functioning as they did prior to the ruptured aneurysm is a lasting memory 
deficit.
Prior approaches to this issue include goal management training and cognitive therapy.  
Goal management training has been proven to be effective in executive function 
rehabilitation following brain injury in adults (8). GMT is a rehabilitation technique aimed 
at helping patients with executive impairments to better structure (instrumental) activities 
of daily living ((i)ADL). GMT entails learning and applying an algorithm, in which complex 
tasks are subdivided into multiple task steps. Both, the final goal and the task steps leading 
to this goal have to be kept active in working memory due in part that GMT is focused on 
making one aware of the cognitive weakness one has to allow for a behavioral change to 
modify the outcome. Unfortunately, working memory processes are often impaired in 
patients with executive deficits. GMT focuses on changing the particular strategy for 
completing a task rather than targeting the specific deficit (8). Monitoring goal-directed 
behavior and the correct execution of task steps are the main aims of GMT, which requires 
sustained attention to allow for change (8). 
Another option is cognitive therapy, which focuses on one particular area of interest such as 
working memory, reasoning or processing speed.  A small study in Sweden was able to 
show that cognitive therapy provided benefits in working memory, attention and overall 
reduced the subjective cognitive complaints after 5 weeks of intervention for patients after 
stroke (9,10). 
What may be more helpful to these patients is a resource that is more convenient, less 
costly, and yet effective in alleviating the types of memory difficulties oftentimes seen after 
SAH.  Online-based cognitive interventions may represent one such option.  Online cognitive 
interventions are becoming increasingly available and offer easier access, easier delivery, 
and the ability to track and analyze performance on these exercises in an automated 
fashion.  Administering exercises using paper and face-to-face encounters requires 
significant time and effort to deliver.  Lumosity, one such program, claims to bolster 
cognitive performance by regular engagement in various games and mental exercises.  It 
has been studied in patients with cancer related and traumatic brain injury patients.  
Significant improvements in processing speeds, mental flexibility and memory have been 
reported.  No similar interventions have been reported in patients within the first few 
months after an aneurysmal SAH.  Given the unique characteristics of many patients who 
survive a ruptured brain aneurysm, and the feasibility of using online cognitive 
interventions, we sought to evaluate its effect through a clinical randomized control study.        
Study Plan: 
Our study aims to determine if periodic online cognitive exercises improve memory 
function in ruptured cerebral aneurysm patients with disabling baseline memory deficits 
within the first 12 months.  Eligible subjects will be physically independent but have a self-
reported disabling memory deficit within the first year of their ruptured cerebral aneurysm.  
Screening will be determined by a series of questions either in person or over the 
telephone.  All enrolled subjects will complete memory assessments to determine baseline 
function.  
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Assessments:  
Redcap administered assessments:
1.  CLCE-24
This questionnaire was originally designed to be a diagnostic instrument for clinicians 
treating patients after a subarachnoid hemorrhage. This questionnaire addresses the most 
common cognitive and emotional complaints for patients who have experienced a 
subarachnoid hemorrhage highlighting the number of unresolved sequelae from a 
subarachnoid hemorrhage. The average number of complaints in this survey is 3.3 with 2.3 
from cognitive and 1 from emotion problems. This study does not have a normal value but 
rather it was found that those that score higher were found to correlate with significantly 
lower CAMCOG (a standardized instrument for the diagnosis and grading of dementia) and 
MMSE (Mini-mental status exam) scores compared to those without complaints.  This 
questionnaire shows no significant differences in scoring regardless for age, gender or 
education.
 
2.  Working memory 
This questionnaire was developed to assess the different areas of working memory 
including attention, executive function and working memory allowing patients to self-
report their problems, which is beneficial for this patient population due to the awareness 
of their memory deficits. This questionnaire was developed for patients who had TBI, 
ischemic or hemorrhagic strokes. This survey allows us to not only assess what aspect of 
working memory is affected but also allows us to grade the severity. The test divides each 
question in to the sub-section it is testing and allots 40 points per section or 120 total. The 
average score of healthy individuals is 17.8 (SD:11.5) whereas, those with brain injury 34.5 
(SD: 22.1)
3.  Activity of Daily Living
To determine the extent by which these problems affect daily life for the individual, we are 
including the Activity of Daily Living (ADL) questionnaire.  This survey assesses standard 
areas of daily living to determine the number as well as the severity of the problem. This 
survey was designed such that patients with cognitive decline could still yield meaningful 
responses.  This test determined normative values based on comparing a patient's baseline 
status to their overall score on the survey, which allows it to be sensitive to mild decline as 
well as severe decline in cognitive function.  The test is scored by taking the total score of a 
patient and dividing by the number of items rated which allows the test to only measure 
deficits seen with activities that the patient regularly participates in. This test has a 
validated cut off points for determine positive results: 0-33% may indicate some 
impairment, 34-66% moderate impairment, 67+%: severe impairment.
Lumosity administered assessments:
1.  Arithmetic Reasoning
2.  Forward Memory Span
3.  Reverse Memory Span
4.  Digit Symbol Coding
5.  Divided Visual Attention
6.  Trail Making A
7.  Trail Making B
8.  Progressive Matrices
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Then, randomization will occur to a treatment group, which will include online access to 
structure-oriented activities(Lumosity), and an active control group(online crosswords).  
Intervention group:  Participants assigned to the intervention/experimental group will 
undergo twenty training sessions over 10 weeks. In each session, they practice video games 
selected from Lumosity(http://www.lumosity.com), a web-based cognitive training 
platform that includes games designed with the purpose of improving the user's cognitive 
abilities (Stemberg et al., 2013).  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.
Game Name
Targeted Skill
Brain Shift
Task Switching
Brain Shift 
Overdrive
Task Switching
By the Rules
Logical Reasoning
Chalkboard 
Challenge
Quantitative 
Reasoning
Color Match
Response Inhibition
Disconnection
Task Switching
Disillusion
Task Switching
Division 
Storm
Numerical 
Calculation
Ebb and Flow
Task Switching
Face Memory 
Workout
Working Memory
Familiar 
Faces
Face-Name Recall
Follow that 
Frog
Working Memory
Lost in 
Migration
Selective Attention
Memory Lane
Working Memory
Memory 
Match
Working Memory
Memory 
Match 
Overdrive
Working Memory
Memory 
Matrix
Spatial Recall
Moneycomb
Spatial Recall
Monster 
Garden
Working Memory
Pet Detective
Planning
Pinball Recall
Working Memory
Playing Koi
Divided Attention
Raindrops
Numerical 
Calculation
Rhyme 
Workout
Working Memory
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River Ranger
Information 
Processing
Rotation 
Matrix
Working Memory
Route to 
Sprout
Planning
Star Search
Selective Attention
Tidal 
Treasures
Working Memory
Train of 
Thought
Divided Attention
Trouble 
Brewing
Divided Attention
Word Sort
Logical Reasoning
Lumosity has the ability to customize games based on the performance in five different 
cognitive domains.  Based on the participants’ performance on exercises testing speed, 
memory, attention, flexibility and problem solving, certain online games can be emphasized 
based on the needs of the patient.  Of interest will also be the profile of cognitive deficits 
determined by the Lumosity screening process that may characterize the cognitive 
problems typically seen in patients with ruptured cerebral aneurysms.   Based on prior 
literature, we will be focusing on games designed to improve divided attention, flexibility, 
problem solving and memory
The recommended interaction would be 2 hours per week for 10 weeks for a total training 
time of 20 hours over the course of the study.  
Active control group:  The attention control group uses a computerized crossword puzzle 
game.  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.  There is, however, no progressive challenge to the user by either increased 
speed, visual field size, number of distractors, or degree of difficulty of target stimulus 
differentiation.  Thus, the crossword puzzle program provides an appropriate, 
computerized attention control alternative to the active visual speed of processing training. 
To facilitate rapid recruitment into the study, randomization stratification will not be 
performed. After 10 weeks, both groups will complete the assessments that were used at 
enrollment.  
Research Methods and Procedures for Post SAH Memory Study
Recruitment and Screening: 
Recruitment: Study participants will be recruited in the following ways: 
A.
Neurosurgery Clinic Setting:
a.
Patients with ruptured aneurysms that will be coming in for follow up at Rush’s 
Neurosurgery Clinic Office can be recruited for the study.  If a patient is deemed a good 
candidate for the study by Dr. Michael Chen or Megan Konopka, they will discuss the study 
with the patient at the end of their clinic visit. If the patient is willing to participate, they 
may be consented.  After agreeing, patients will be sent an email with a secured link via 
REDCap to fill out a demographics survey.   
B.
Email and Phone Screen Setting:
a.
Dr. Chen has composed a recruitment letter to patients that can be emailed. With that letter, 
patients will receive contact information of who to call if interested in the study. The contact 
will be the Neurosurgery Department’s research coordinator Michelle Smreczak. It will be 
the coordinator’s responsibility to screen these potential participants over the phone. At 
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this point, if the patient qualifies and agrees to the study, a telephone script of the consent 
will be read to the patients. After agreeing, patients will be sent an email with a secured link 
via REDCap to fill out a demographics survey.
C.
Social Media 
a.
Via the Brain Aneurysm Foundation or the Joe Niekro Foundation
i.
Survivors who meet the inclusion criteria via a telephone interview, will be 
enrolled in the study.  
D. Support Group Setting at Rush University Medical Center:
a.
Patients with ruptured aneurysms that attend a Rush initiated monthly support 
group will be recruited for this study. Recruitment scripts will be provided to the 
facilitator of the group. If patients are interested in participating, they will be able to 
speak with Investigator Megan Konopka and sign a consent form after the monthly 
meeting. Both the facilitator and Investigators will make it very clear in their scripts 
that participation in the study is voluntary and not necessary to do as part of the 
support group meetings.  
Data Collection Methods: 
A.
REDCap is a secure web application that is used for building and managing online surveys 
and databases. The REDCap Consortium is composed of 1,308 active institutional partners 
in 88 countries who utilize and support the system. REDCap will be used for the following in 
this proposed study:
a.
Participant Randomization
1.
Study staff will be utilizing REDCap’s randomization tool. The 
randomization tool has been formatted to randomize patients into 
one of two groups, “Lumosity” or “active control”.  Stratification 
factors will include age (<50, 50 or older), gender, level of 
education (greater than high school education or not) and time 
since rupture of the aneurysm (<6 months or 6-12 months). 
Randomization by the study staff will occur when the participant 
completes the demographic survey. This tool will help the study 
better implement a defined randomization model and allow the 
study staff to randomize participants easily.  
Screen shots of the Project’s Randomization Tool: 
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b.
Delivery of patient surveys
1.
Surveys (CLCE-24, Working Memory, and Activities of Daily Living 
ADL Scale) will be sent to participants via the REDCap system. Study 
participants will be able to complete all surveys and submit them 
online. Individual emails are sent out to each person in the study. 
The email will contain brief instructions about completing the survey 
and a secured link to their individual survey queue.
Screen shot of the Survey Queue:
c.
Collection of Survey Responses:
1.
The REDCap database will alert the study team on which surveys 
were and were not completed by specific participants. The study 
staff will be able to send reminders to those who have not yet 
completed all the required surveys in their queue.
Screen shot of the participant list: 
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d.
Data Export
1.
When survey information is collected, the study team will be able to 
analyze the data that has populated into REDCap in many different 
ways. The Data can be exported into many different programs such 
as SPSS or excel. 
Screen 
shot of 
the 
data 
export 
options: 
Screening Process:
Objective:  To best validate that the subject, particularly those who are not actual patients, 
have the index disease being studied.
Screening Questions:
1.
What were your symptoms that led to the diagnosis of a brain aneurysm?
2.
Did anybody actually tell you that you had bleeding in your head?
3.
How long did you stay in the hospital?
4.
What did they say caused the bleeding in the brain?
5.
How was the aneurysm treated?
6.
Are you able to dress yourself, clean yourself and feed yourself?
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7.
Have you had problems with remembering things, such as appointments, 
responsibilities that have affected your daily life/activities?
8.
Do you feel like you have a problem with memory since your aneurysm rupture?
Inclusion/Exclusion Criteria: 
Inclusion
Ruptured cerebral aneurysm-confirmed by study personnel within past year
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
Unable to read or speak English
Data Analysis: 
Data will be analyzed by a Spearman rank-order correlation. Data will be compared by 
using the number of completed puzzles and the amount of time spent completing them with 
changes noted on the CLCE-24 and working memory questionnaires. The Spearman rank-
order will be used to show a monotonic relationship with completing strategy orientated 
puzzle and reduction in memory symptoms. 
Table of Expected Results 
Testing
Baseline
Post Intervention
Controls 
CLCE-24
Cognitive and Emotional 
complaints: 3.3
Cognitive and 
emotional complaints: 1
Cognitive and 
emotional complaints: 
3
ADLQ
Total: 17/84 or 20%
Total: 10/84 or 11%
Total: 18/84 or 21% 
Working 
Memory 
Total: 34.5
Storage: 11
Attention: 14
Executive Function: 9
Total: 20
Storage: 6
Attention: 8
Executive Function: 6
Total: 32
Storage: 10
Attention: 14
Executive Function: 8
Estimated sample size:  108 subjects total.
For CLCE-24, a sample size of 50 patients per group (total of 100 patients) can provide 80% 
power to detect a difference of 2 in number of complaints between the two groups, with a 
significance level of 0.5 and using a two-sample t-test (two-sided).  For the Working 
memory questionnaire, a sample size of 54 patients per group (total of 108 patients) will 
achieve 80% power to detect a difference of 12 points between the two groups, with a 
significance level of 0.5 and using a two-sample t-test (two-sided).
Data Collection: 
Data will be collected at different time points in this study. Please refer to table 1 for further 
reference. 
Week 1: Consent, enrollment, completion of three Redcap assessments and Lumosity 
assessments.  Randomization.  Intervention group will receive access to Lumosity and 
control will get access to crossword puzzles. 
Weeks 2-9: Intervention group will be reminded to complete Lumosity games; active 
controls will be reminded to complete cross-word puzzles
Week 10: All subjects complete the three Redcap assessments, the Lumosity assessments.   
Study completed at this time.
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Table 1. 
Group
Week 1
Weeks 
2-9
Week 10
Intervention
CLCE24/Working 
memory/ADLs/Lumosity
X
x
Lumosity
x
x
X
Control
CLCE24/Working 
memory/ADLs/Lumosity
X
X
Active control
x
X
*At 70 day assessment, patients will have a +/-10 day window to submit questionnaires. 
Data Analysis:  The primary analysis should be comparisons between the two groups for 
the outcome measures. T test or Mann-Whitney test can be used for comparisons and 
regression analysis may be performed with adjustment of baseline characteristics.
Questionnaires
For the CLCE-24, Working Memory and Activities of Daily Living Questionnaire, please see Appendix A.
Processes and controls to ensure study integrity
A key differentiator in this study is the use of online consent, data acquisition and data 
analysis.  A concern for data being collected in this fashion concerns sampling bias and 
construct validity. One might think that support groups and online social networks may not 
capture data from patients who are older and not as familiar with technology.  However, as 
social media improves its user interface, greater numbers of older users are being engaged.  
We believe Lumosity represents one such solution to address this concern.  With regard to 
construct validity, we have included a series of questions we will administer over the phone 
in the event subjects are not actual patients of our practice for whom we have been able to 
review the relevant history, physical examination and imaging findings.  Users of targeted 
social network groups are likely to be a self-selected motivated group of individuals. The 
likelihood that individuals without a diagnosis of brain aneurysm would be a part of this 
targeted social network and participate in the study seems unlikely.  We hope that the 
relatively larger size of the dataset relative to previously published single-center series can 
overcome the effect any erroneous outliers may have on biasing the data.
Suitability of investigator(s) and institution
Michael Chen, MD is a board-certified, Associate Professor at Rush University Medical 
Center.  He has over 10 years of experience caring for patients with vascular disease of the 
brain and spine.  As such, annual office visits from patients with cerebral aneurysms 
average between 150-200.  He has been interviewed on ABC, FOX and CBS news as well 
as the Chicago Tribune and the Wall Street Journal.  He's been awarded research grants, 
authored over 50 peer-reviewed scientific papers, invited to speak at national and 
international meetings, and is an associate editor for the Journal of Neuro-interventional 
Surgery.  He serves on the Scientific Advisory Boards for the Niekro Foundationand the Bee 
Foundation.  He was elected to the Rush University Medical Staff Executive Committee.    He 
serves on the Standards & Guidelines Committee for the Society for Neurointerventional 
Surgery.
Dr. Chen has engaged national brain aneurysm support groups to conduct online 
questionnaires evaluating hypothesis-driven questions on quality of life issues among 
patients with ruptured brain aneurysms.  In 2014, he published an article, “Patient-reported 
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outcome measures for patients with cerebral aneurysms acquired via social media: data 
from a large nationwide sample” in the Journal of Neurointerventional Surgery whereby 
data from over 600 subjects over a 2 month span across 47 states in the United States was 
obtained  Valuable networks and experience were gained from this experience to conduct 
future clinical studies leveraging social media.    
Rush University Medical Center and the Department of Neurological Surgery is a tertiary 
care, academic urban 800-bed medical center in Chicago, Illinois.  We perform the largest 
number of neurosurgical cases in the city and have been invited to participate in multiple 
studies evaluating new devices and technologies.  We have a monthly support group in our 
Neurosurgery office for brain aneurysm survivors in conjunction with the Joe Niekro 
Foundation.  
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