NCT03933020

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 19, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

21 days

First QC Date

April 24, 2019

Results QC Date

January 13, 2022

Last Update Submit

May 17, 2022

Conditions

Pediatric Onset Multiple Sclerosis (POMS)

Keywords

Multiple SclerosisCognitive ImpairmentPhysical activity

Outcome Measures

Primary Outcomes (9)

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

    3 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

    6 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)

    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

    12 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

    3 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

    6 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)

    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

    12 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

    3 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

    6 months

  • Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised

    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 months

Secondary Outcomes (18)

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    3 Month

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    6 month

  • Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    12 month

  • Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)

    3 months

  • Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)

    6 month

  • +13 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL
Device: VR active video game interventionBehavioral: Educational session

Control Group

ACTIVE COMPARATOR
Behavioral: Standard Management of Physical Activity

Interventions

VR active video game interventionDEVICE

The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise

Exercise Group
Educational sessionBEHAVIORAL

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.

Exercise Group
Standard Management of Physical ActivityBEHAVIORAL

Routine discussion of lifestyle factors including physical activity during clinic visits

Control Group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of visual provoked seizures
  • EDSS \> 5.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center,Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple SclerosisCognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Results Point of Contact

Title
Rohini D. Samudralwar, MD
Organization
The University of Texas Health Science Center at Houston
Rohini.D.Samudralwar@uth.tmc.edu
(832) 325-7077

Study Officials

  • Stephanie Garcia-Tarodo, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 1, 2019

Study Start

May 10, 2019

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

May 19, 2022

Results First Posted

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)