MASH: Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02864940

Collaborator

Lumos Labs, Inc. (Industry)

Enrollment

Location

Arms

26.9

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ruptured Aneurysm Memory Deficits Subarachnoid Hemorrhage	Device: Lumosity Device: Crossword puzzle	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2016

Actual Primary Completion Date :

Aug 15, 2018

Actual Study Completion Date :

Aug 28, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cognitive and Emotional complaints [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 [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) [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.