Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (MASH)

Rush

Status: Terminated

Conditions: Subarachnoid Hemorrhage; Memory Deficits; Ruptured Aneurysm

Treatments: Device: Crossword puzzle; Device: Lumosity

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02864940

MASH 14080402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Using the cognitive exercises on Lumosity for 10 weeks

Treatment:

Device: Lumosity

Control Arm

Active Comparator group

Description:

Using online crossword puzzles for 10 weeks.

Treatment:

Device: Crossword puzzle