NCT02318576

Brief Summary

This study seeks to examine whether 12 weeks of home-based computerized cognitive training on Cognitive Motor Interference (CMI) will improve walking and cognitive function in persons with MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

December 9, 2014

Last Update Submit

October 25, 2016

Conditions

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Cognitive motor interference meausred by the percent change in walking velocity from single (walking only) to dual task (walking while thinking).

    CMI will be operationalized as the percent change in walking velocity from single (walking only) to dual task (walking while thinking). Participants will complete a total of 4 walking trials over a 20' pressure sensitive (Zeno™) walkway at a comfortable pace. Half of the trials will be conducted while reciting every other letter of the alphabet (i.e. N, P, R, etc). Each trial will start with a different letter to minimize practice effects. The order of the dual task conditions will be counter balanced. Prior to walking trails participants will complete the alternating letter task for two 10-second trials while seated.

    12 weeks

Secondary Outcomes (1)

  • Cognitive Function

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

This group will do nothing for the 12 week program.

Cognitive Trained Group

EXPERIMENTAL

This group will train three time a week for one hour on the given computerized cognitive training website for the 12 week program.

Other: Cognitive Training

Interventions

Computerized Cognitive Training: The online computer training program will be administered on the participants' home computer. The training program will consist of a total of 36 sessions (3 times/week for 12 weeks). Each session will last no more than 60 minutes and consist of five different cognitive exercises designed to improve cognitive processing speed, memory and executive function. All exercises will involve visual stimuli and a motor response (key or button press). Exercises will be adaptive to participants' individual ability and start with minimal difficulty.

Cognitive Trained Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medically confirmed MS diagnosis, relapse free in the last 30 days, willingness to complete 12 week intervention, a computer with Internet access and capacity to run the cognitive training software, and a willingness to travel twice to our research lab.

You may not qualify if:

  • Non-ambulatory, inability to see/read computer screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motor control research lab

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jacob J Sosnoff, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 17, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations