Clinical trial NCT03933020: Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)
Official title: Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Onset Multiple Sclerosis (POMS)
Keywords: Multiple Sclerosis
Cognitive Impairment
Physical activity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Microsoft Corporation
First posted: 2019-05-01
Enrollment: 2
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
timeFrame: 3 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
timeFrame: 6 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
timeFrame: 12 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
timeFrame: 3 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
timeFrame: 6 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
timeFrame: 12 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
timeFrame: 3 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
timeFrame: 6 months
measure: Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
timeFrame: 12 months
Secondary outcomes:
measure: Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: 3 Month
measure: Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: 6 month
measure: Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: 12 month
measure: Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
timeFrame: 3 months
measure: Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
timeFrame: 6 month
measure: Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
timeFrame: 12 month
measure: Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 month
measure: Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 month
measure: Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 month
measure: Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
timeFrame: 6 months
measure: Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
timeFrame: 12 months
measure: Number of Clinical Relapses
timeFrame: 12 months
measure: New Activity on MRI (T2 Lesions, Gd+)
timeFrame: 12 months
measure: 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.
timeFrame: 1 month
measure: 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.
timeFrame: 3 month
measure: 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.
timeFrame: 6 month
measure: Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
timeFrame: 6 months
measure: Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center,Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stephanie Garcia-Tarodo, MD
role: PRINCIPAL_INVESTIGATOR
References: