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| Name | Class |
|---|---|
| Lumos Labs, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Using the cognitive exercises on Lumosity for 10 weeks |
|
| Control Arm | Active Comparator | Using online crossword puzzles for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumosity | Device | A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| 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. | One Year |
| 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 | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16943405 | Background | Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available. | |
| 21435599 | Background | Rinkel GJ, Algra A. Long-term outcomes of patients with aneurysmal subarachnoid haemorrhage. Lancet Neurol. 2011 Apr;10(4):349-56. doi: 10.1016/S1474-4422(11)70017-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
18 subjects in the control arm completed the pre-intervention assessments for CLCE-24, working memory and Activities of daily living.
20 subjects in the Intervention arm completed the pre-intervention assessments for CLCE-24, and Activities of daily living. 19 subjects completed the working memory assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intervention Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment. | Posted | Mean | Full Range | score on scale | One year |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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No subjects analyzed due to incomplete data, leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Chen, MD | Rush University Medical Center | 312-563-2817 | Michael_Chen@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2015 | Dec 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017542 | Aneurysm, Ruptured |
| D008569 | Memory Disorders |
| D013345 | Subarachnoid Hemorrhage |
| D000783 | Aneurysm |
| D012421 | Rupture |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Crossword puzzle | Device | 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. |
|
| 20375498 | Background | Passier PE, Visser-Meily JM, van Zandvoort MJ, Post MW, Rinkel GJ, van Heugten C. Prevalence and determinants of cognitive complaints after aneurysmal subarachnoid hemorrhage. Cerebrovasc Dis. 2010;29(6):557-63. doi: 10.1159/000306642. Epub 2010 Apr 8. |
| 22325677 | Background | Sheldon S, Macdonald RL, Schweizer TA. Free recall memory performance after aneurysmal subarachnoid hemorrhage. J Int Neuropsychol Soc. 2012 Mar;18(2):334-42. doi: 10.1017/S1355617711001780. Epub 2012 Feb 13. |
| 23871092 | Background | Sheldon S, Macdonald RL, Cusimano M, Spears J, Schweizer TA. Long-term consequences of subarachnoid hemorrhage: examining working memory. J Neurol Sci. 2013 Sep 15;332(1-2):145-7. doi: 10.1016/j.jns.2013.06.021. Epub 2013 Jul 18. |
| 24040927 | Background | Al-Khindi T, Macdonald RL, Schweizer TA. Decision-making deficits persist after aneurysmal subarachnoid hemorrhage. Neuropsychology. 2014 Jan;28(1):68-74. doi: 10.1037/neu0000003. Epub 2013 Sep 16. |
| 25452396 | Background | Chen M, Mangubat E, Ouyang B. Patient-reported outcome measures for patients with cerebral aneurysms acquired via social media: data from a large nationwide sample. J Neurointerv Surg. 2016 Jan;8(1):42-6. doi: 10.1136/neurintsurg-2014-011492. Epub 2014 Dec 1. |
| 21369362 | Background | Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011. |
| 17364516 | Background | Westerberg H, Jacobaeus H, Hirvikoski T, Clevberger P, Ostensson ML, Bartfai A, Klingberg T. Computerized working memory training after stroke--a pilot study. Brain Inj. 2007 Jan;21(1):21-9. doi: 10.1080/02699050601148726. |
| 17179457 | Background | Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805. |
| 12425704 | Background | Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271. |
| 11514044 | Background | Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8. |
| 17126480 | Background | van Heugten C, Rasquin S, Winkens I, Beusmans G, Verhey F. Checklist for cognitive and emotional consequences following stroke (CLCE-24): development, usability and quality of the self-report version. Clin Neurol Neurosurg. 2007 Apr;109(3):257-62. doi: 10.1016/j.clineuro.2006.10.002. Epub 2006 Nov 28. |
| 22537095 | Background | Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27. |
| 15592135 | Background | Johnson N, Barion A, Rademaker A, Rehkemper G, Weintraub S. The Activities of Daily Living Questionnaire: a validation study in patients with dementia. Alzheimer Dis Assoc Disord. 2004 Oct-Dec;18(4):223-30. |
| 23650501 | Background | Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults. PLoS One. 2013 May 1;8(5):e61624. doi: 10.1371/journal.pone.0061624. Print 2013. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Data was not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| CLCE-24 | 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. | Mean | Full Range | Number of complaints |
|
| 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 5 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 | One subject did not complete the working memory assessment | Mean | Full Range | Units on a Scale |
|
| 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 | Mean | Full Range | percentage of impairment |
|
| OG001 |
| Intervention Arm |
Lumosity |
|
|
| 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. | only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment. | Posted | Mean | Full Range | Units on a scale | One Year |
|
|
|
| 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 | only 7 subjects in the control arm and 7 subject in the intervention arm participated in the games and completed their post assessment. | Posted | Mean | Full Range | percentage of impairment | One year |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010335 | Pathologic Processes |
| D014947 | Wounds and Injuries |