Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

Subarachnoid Hemorrhage Clinical Trial

— MASH  

Official title:

MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02864940
• Other study ID #: MASH 14080402
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: March 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: August 28, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Hemorrhage
• Memory Deficits
• Memory Disorders
• Ruptured Aneurysm
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	One year
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.	One Year
Primary	Activity of Daily Living	Activities of daily living: Each answered question was rated on a ?ve-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