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Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

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ClinicalTrials.gov Identifier: NCT03933020
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Microsoft Houston
Information provided by (Responsible Party):
Stephanie Garcia-Tarodo, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).

Condition or disease Intervention/treatment Phase
Pediatric Onset Multiple Sclerosis (POMS) Device: VR active video game intervention Behavioral: Educational session Behavioral: Standard Management of Physical Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : July 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Group Device: VR active video game intervention
The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise

Behavioral: Educational session
This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.

Active Comparator: Control Group Behavioral: Standard Management of Physical Activity
Routine discussion of lifestyle factors including physical activity during clinic visits




Primary Outcome Measures :
  1. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  2. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  3. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 6 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  4. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  5. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: Baseline ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  6. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 3 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  7. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 6 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  8. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 12 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  9. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: Baseline ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

  10. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 3 months ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

  11. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 6 months ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

  12. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 12 months ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).


Secondary Outcome Measures :
  1. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: baseline ]
    29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.

  2. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 3 Month ]
    29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.

  3. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 6 month ]
    29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.

  4. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 month ]
    29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.

  5. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline ]
    21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.

  6. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 3 months ]
    21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.

  7. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 6 month ]
    21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.

  8. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 12 month ]
    21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.

  9. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline ]
    14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.

  10. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 month ]
    14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.

  11. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 month ]
    14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.

  12. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 month ]
    14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.

  13. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: Baseline ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  14. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 6 months ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  15. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 12 months ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  16. Number of clinical relapses [ Time Frame: 12 months ]
    Assessment at each clinic visit

  17. New activity on MRI (T2 lesions, Gd+) [ Time Frame: 12 months ]
    Assessment at each MRI

  18. Safety of implementing a VR active video game program at home as assessed by the number of self-reported incidents that occur during the exercise sessions, including falls or physical injuries. [ Time Frame: 1 month ]
  19. Safety of implementing a VR active video game program at home as assessed by the number of self-reported incidents that occur during the exercise sessions, including falls or physical injuries. [ Time Frame: 3 month ]
  20. Safety of implementing a VR active video game program at home as assessed by the number of self-reported incidents that occur during the exercise sessions, including falls or physical injuries. [ Time Frame: 6 month ]
  21. Degree of incorporation of physical activity into daily life as assessed by a self report questionnaire [ Time Frame: 6 months ]
  22. Degree of incorporation of physical activity into daily life as assessed by a self report questionnaire [ Time Frame: 12 months ]


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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Pediatric-Onset MS (<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting)
  • Expanded Disability Status Scale (EDSS) ≤ 5.0
  • Relapse free for the past 30 days (including no corticosteroids)
  • No contraindications to physical activity, including pregnancy
  • Participant and parent (if between 15 and 18 years of age) written informed consent.

Exclusion Criteria:

  • History of visual provoked seizures
  • EDSS > 5.0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933020


Contacts
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Contact: Stephanie Garcia-Tarodo, MD 832-294-5402 Stephanie.GarciaTarodo@uth.tmc.edu
Contact: Rohini Samudralwar, MD 832-325-7077 Rohini.D.Samudralwar@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center,Houston Recruiting
Houston, Texas, United States, 77030
Contact: Carlos Perez, MD       Carlos.A.Perez@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Microsoft Houston
Investigators
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Principal Investigator: Stephanie Garcia-Tarodo, MD The University of Texas Health Science Center, Houston

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Responsible Party: Stephanie Garcia-Tarodo, Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03933020     History of Changes
Other Study ID Numbers: HSC-MS-19-0247
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Stephanie Garcia-Tarodo, The University of Texas Health Science Center, Houston:
Multiple Sclerosis
Cognitive Impairment
Physical activity

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases