Clinical trial NCT02864940: Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients
Official title: MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ruptured Aneurysm
Memory Deficits
Subarachnoid Hemorrhage
Keywords: Memory
aneurysm
deficits
trouble
forgetful
ruptured
subarachnoid
hemorrhage
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Lumos Labs, Inc.
First posted: 2016-08-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CLCE-24
timeFrame: One year
measure: Working Memory
timeFrame: One Year
measure: Activity of Daily Living
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
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