Trial Outcomes & Findings for Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (NCT NCT02864940)
NCT ID: NCT02864940
Last Updated: 2023-04-10
Results Overview
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.
TERMINATED
NA
38 participants
One year
2023-04-10
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Using the cognitive exercises on Lumosity for 10 weeks
Lumosity: A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
Intervention Arm
Using the cognitive exercises on Lumosity for 10 weeks
Lumosity: A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
|
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.
|
|---|---|---|
|
Overall Study
Never took part in intervention or control arm activities or completed post assessments
|
13
|
11
|
Baseline Characteristics
Data was not collected.
Baseline characteristics by cohort
| Measure |
Control Arm
n=18 Participants
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.
|
Intervention Arm
n=20 Participants
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.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=18 Participants
|
19 Participants
n=20 Participants
|
35 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=38 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Data was not collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Data was not collected.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
CLCE-24
|
13.7 Number of complaints
n=18 Participants
|
12.1 Number of complaints
n=20 Participants
|
12.9 Number of complaints
n=38 Participants
|
|
Working memory
|
36.17 Units on a Scale
n=18 Participants • One subject did not complete the working memory assessment
|
38 Units on a Scale
n=19 Participants • One subject did not complete the working memory assessment
|
37 Units on a Scale
n=37 Participants • One subject did not complete the working memory assessment
|
|
Activity of Daily Living
|
32 percentage of impairment
n=18 Participants
|
23 percentage of impairment
n=20 Participants
|
27.5 percentage of impairment
n=38 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
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.
Outcome measures
| Measure |
Control Arm
n=7 Participants
Crossword
|
Intervention Arm
n=7 Participants
Lumosity
|
|---|---|---|
|
CLCE-24
|
12.6 score on scale
Interval 9.0 to 14.0
|
10.4 score on scale
Interval 7.0 to 15.0
|
PRIMARY outcome
Timeframe: One YearPopulation: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
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.
Outcome measures
| Measure |
Control Arm
n=7 Participants
Crossword
|
Intervention Arm
n=7 Participants
Lumosity
|
|---|---|---|
|
Working Memory
|
35.8 Units on a scale
Interval 14.0 to 51.6
|
31.4 Units on a scale
Interval 9.2 to 53.3
|
PRIMARY outcome
Timeframe: One yearPopulation: only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment.
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
Outcome measures
| Measure |
Control Arm
n=7 Participants
Crossword
|
Intervention Arm
n=7 Participants
Lumosity
|
|---|---|---|
|
Activity of Daily Living
|
23.7 percentage of impairment
Interval 10.7 to 35.7
|
18.9 percentage of impairment
Interval 2.6 to 29.6
|
Adverse Events
Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place