Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

NCT02864940 | Terminated Results DMC

• 1 other identifier: MASH 14080402
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Aneurysm; Memory Deficits; Subarachnoid Hemorrhage

Keywords

Memory; aneurysm; deficits; trouble; forgetful; ruptured; subarachnoid; hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Using the cognitive exercises on Lumosity for 10 weeks

Device: Lumosity

Control Arm

ACTIVE COMPARATOR

Using online crossword puzzles for 10 weeks.

Device: Crossword puzzle

Interventions

Lumosity DEVICE

A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities

Intervention Arm

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to read or speak English

Sponsors & Collaborators

• Rush University Medical Center: lead
• Lumos Labs, Inc.: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (16)

• 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.

  PMID: 16943405 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.

  PMID: 21435599 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.

  PMID: 20375498 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.

  PMID: 22325677 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.

  PMID: 23871092 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.

  PMID: 24040927 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.

  PMID: 25452396 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.

  PMID: 21369362 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.

  PMID: 17364516 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.

  PMID: 17179457 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.

  PMID: 12425704 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.

  PMID: 11514044 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.

  PMID: 17126480 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.

  PMID: 22537095 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.

  PMID: 15592135 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.

  PMID: 23650501 BACKGROUND

MeSH Terms

Conditions

Aneurysm, Ruptured; Memory Disorders; Subarachnoid Hemorrhage; Aneurysm; Rupture; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Pathologic Processes; Wounds and Injuries

Limitations and Caveats

No subjects analyzed due to incomplete data, leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Michael Chen, MD
• Organization: Rush University Medical Center

Michael_Chen@rush.edu

312-563-2817

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Neurosurgery and Radiology

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 12, 2016
• Study Start: June 1, 2016
• Primary Completion: August 15, 2018
• Study Completion: August 28, 2018
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)