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Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (MASH)

Primary Purpose

Ruptured Aneurysm, Memory Deficits, Subarachnoid Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumosity
Crossword puzzle
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Aneurysm focused on measuring Memory, aneurysm, deficits, trouble, forgetful, ruptured, subarachnoid, hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • Unable to read or speak English

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

Using the cognitive exercises on Lumosity for 10 weeks

Using online crossword puzzles for 10 weeks.

Outcomes

Primary Outcome Measures

CLCE-24
Cognitive and Emotional Consequences CLCE-24-C, which consists of 13 items (e.g., problems with "doing two things at once" or "remembering new information" . The items involve multiple cognitive domains (including executive functioning, attention, memory, speed of processing and visuospatial perception) and are indicative of the cognitive complaints the patient experiences. The interviewer scores a "0" for the absence of complaints, a "1" for possible complaints and a "2" for the presence of complaints. Total scores range from 0-26 and higher scores indicate more cognitive complaints.
Working Memory
Working Memory Questionnaire - 30 questions in 3 different domains of 10 questions each. First domain short term storage, second domain was attention, third domain executive aspects of working memory such as decision making, planning ahead or shifting. Each question 6 point Likert scale (0-5), three domains, maximal score 50 each for total score out of 150 with higher scores corresponding to more difficulties/complaints. Total score ranges from 0-150, with higher scores corresponding to more difficulties/complaints.
Activity of Daily Living
Activities of daily living: Each answered question was rated on a five-point Likert-type scale, ranging from 0 (no problem at all) to 4 (very severe problem in everyday life). Test is scored by taking the total score of a patient and dividing by the number of items rated and converted to percentiles, allows test to measure deficits seen with regular activities. Total score ranges from 0-100%. Test has a validated cut off points for determine positive results: 0-33% may indicate some impairment, 34-66% moderate impairment, 67+%: severe impairment. Higher values = worse outcomes

Secondary Outcome Measures

Full Information

First Posted
August 5, 2016
Last Updated
March 16, 2023
Sponsor
Rush University Medical Center
Collaborators
Lumos Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02864940
Brief Title
Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients
Acronym
MASH
Official Title
MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Lumos Labs, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aim is to determine if periodic online cognitive exercises (Lumosity) improve memory function in ruptured cerebral aneurysm patients with disabling baseline memory deficits within the first 24 months after rupture. Half of the subjects will be randomized to use Lumosity-designed online cognitive exercises and half will serve as an active control group performing online crossword puzzles.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Aneurysm, Memory Deficits, Subarachnoid Hemorrhage
Keywords
Memory, aneurysm, deficits, trouble, forgetful, ruptured, subarachnoid, hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Using the cognitive exercises on Lumosity for 10 weeks
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Using online crossword puzzles for 10 weeks.
Intervention Type
Device
Intervention Name(s)
Lumosity
Intervention Description
A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
Intervention Type
Device
Intervention Name(s)
Crossword puzzle
Intervention Description
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.
Primary Outcome Measure Information:
Title
CLCE-24
Description
Cognitive and Emotional Consequences CLCE-24-C, which consists of 13 items (e.g., problems with "doing two things at once" or "remembering new information" . The items involve multiple cognitive domains (including executive functioning, attention, memory, speed of processing and visuospatial perception) and are indicative of the cognitive complaints the patient experiences. The interviewer scores a "0" for the absence of complaints, a "1" for possible complaints and a "2" for the presence of complaints. Total scores range from 0-26 and higher scores indicate more cognitive complaints.
Time Frame
One year
Title
Working Memory
Description
Working Memory Questionnaire - 30 questions in 3 different domains of 10 questions each. First domain short term storage, second domain was attention, third domain executive aspects of working memory such as decision making, planning ahead or shifting. Each question 6 point Likert scale (0-5), three domains, maximal score 50 each for total score out of 150 with higher scores corresponding to more difficulties/complaints. Total score ranges from 0-150, with higher scores corresponding to more difficulties/complaints.
Time Frame
One Year
Title
Activity of Daily Living
Description
Activities of daily living: Each answered question was rated on a five-point Likert-type scale, ranging from 0 (no problem at all) to 4 (very severe problem in everyday life). Test is scored by taking the total score of a patient and dividing by the number of items rated and converted to percentiles, allows test to measure deficits seen with regular activities. Total score ranges from 0-100%. Test has a validated cut off points for determine positive results: 0-33% may indicate some impairment, 34-66% moderate impairment, 67+%: severe impairment. Higher values = worse outcomes
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Unable to read or speak English
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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16943405
Citation
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Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

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