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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
Sponsor:
Collaborator:
Lumos Labs, Inc.
Information provided by (Responsible Party):
Michael Chen, M.D., Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Ruptured Aneurysm Memory Deficits Subarachnoid Hemorrhage Device: Lumosity Device: Crossword puzzle Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Memory

Arm Intervention/treatment
Experimental: Intervention Arm
Using the cognitive exercises on Lumosity for 10 weeks
Device: Lumosity
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Lumos Labs, Inc.

Publications:

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Responsible Party: Michael Chen, M.D., Associate Professor of Neurology, Neurosurgery and Radiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02864940     History of Changes
Other Study ID Numbers: MASH 14080402
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Michael Chen, M.D., Rush University Medical Center:
Memory
aneurysm
deficits
trouble
forgetful
ruptured
subarachnoid
hemorrhage

Additional relevant MeSH terms:
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Aneurysm
Aneurysm, Ruptured
Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Rupture
Memory Disorders
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms