Memory Deficits, Ruptured Aneurysm, Subarachnoid Hemorrhage
Conditions
Keywords
Memory, aneurysm, deficits, trouble, forgetful, ruptured, subarachnoid, hemorrhage
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.
Interventions
DEVICELumosity
A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
DEVICECrossword 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.
Sponsors
Lumos Labs, Inc.
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CLCE-24 | One year | 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 | One Year | 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 | One year | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Using online crossword puzzles for 10 weeks.
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. | 18 |
| Intervention Arm Participants assigned to the intervention/experimental group will undergo twenty training sessions over 10 weeks. In each session, they practice video games selected from Lumosity(http://www.lumosity.com), a web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities. | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Never took part in intervention or control arm activities or completed post assessments | 13 | 11 |
Baseline characteristics
| Characteristic | Total | Intervention Arm | Control Arm |
|---|---|---|---|
| Activity of Daily Living | 27.5 percentage of impairment | 23 percentage of impairment | 32 percentage of impairment |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 19 Participants | 16 Participants |
| CLCE-24 | 12.9 Number of complaints | 12.1 Number of complaints | 13.7 Number of complaints |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 0 Participants | — | — |
| Sex: Female, Male Male | 0 Participants | — | — |
| Working memory | 37 Units on a Scale | 38 Units on a Scale | 36.17 Units on a Scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Time frame: One year
Population: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | Activity of Daily Living | 23.7 percentage of impairment |
| Intervention Arm | Activity of Daily Living | 18.9 percentage of impairment |
Primary
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.
Time frame: One year
Population: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | CLCE-24 | 12.6 score on scale |
| Intervention Arm | CLCE-24 | 10.4 score on scale |
Primary
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.
Time frame: One Year
Population: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Arm | Working Memory | 35.8 Units on a scale |
| Intervention Arm | Working Memory | 31.4 Units on a scale |