Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients (MASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02864940
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Lumos Labs, Inc.
Information provided by (Responsible Party):
Michael Chen, M.D., Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Cognitive and Emotional complaints [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    The change in scoring from baseline to 10 weeks for the checklist for cognitive and emotional consequences following stroke (CLCE-24) questionnaire will be evaluated.
  • Working memory [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    The change in scoring from baseline to 10 weeks for the working memory test (which assesses the different areas of working memory including attention, executive function and working memory will be evaluated.
  • Activity of Daily Living (ADL) [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    The change in scoring from baseline to 10 weeks for the ADL test (which assesses standard areas of daily living to determine the number as well as the severity of the problem) will be evaluated.
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Cognitive and Emotional complaints [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    We will evaluate for a change in this assessment from baseline to 10 weeks. Checklist for cognitive and emotional consequences following stroke (CLCE-24) questionnaire.
  • Working memory [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    We will evaluate for a change in this assessment from baseline to 10 weeks. This questionnaire was developed to assess the different areas of working memory including attention, executive function and working memory.
  • Activity of Daily Living (ADL) [ Time Frame: Assessed at baseline (day 0) and 10 weeks ]
    We will evaluate for a change in this assessment from baseline to 10 weeks. This survey assesses standard areas of daily living to determine the number as well as the severity of the problem.
Change History Complete list of historical versions of study NCT02864940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients
Official Title  ICMJE MASH Study (Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ruptured Aneurysm
  • Memory Deficits
  • Subarachnoid Hemorrhage
Intervention  ICMJE
  • Device: Lumosity
    A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
  • Device: 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.
Study Arms  ICMJE
  • Experimental: Intervention Arm
    Using the cognitive exercises on Lumosity for 10 weeks
    Intervention: Device: Lumosity
  • Active Comparator: Control Arm
    Using online crossword puzzles for 10 weeks.
    Intervention: Device: Crossword puzzle
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
35
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
108
Actual Study Completion Date  ICMJE August 28, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864940
Other Study ID Numbers  ICMJE MASH 14080402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Michael Chen, M.D., Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Lumos Labs, Inc.
Investigators  ICMJE Not Provided
PRS Account Rush University Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP