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Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Cognitive remediation, Plasticity-based, adaptive, computerized cognitive remediation, Cognitive impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18-70
  • Definite MS Diagnosis, any subtype [83]
  • Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT
  • Concurrent medications to be kept constant over three months (as possible)
  • No relapse or steroids in previous month
  • Reading score on WRAT-3 of 37 or greater
  • Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff
  • Willing to sign Agreement to Borrow Laptop

Exclusion Criteria:

  • History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
  • Primary psychiatric disorder that would influence ability to participate
  • Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
  • Alcohol or other substance use disorder
  • History of computer-based training manufactured by Posit Science
  • Learned English language after 12 years of age

Sites / Locations

  • Stony Brook University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment A

Treatment B

Arm Description

plasticity-based, adaptive, computerized cognitive remediation (PACR)

Ordinary Computer Games (an "active control condition")

Outcomes

Primary Outcome Measures

A composite derived from a standardized battery of neuropsychological tests
Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes

Secondary Outcome Measures

A timed measure based on direct observation of functional performance

Full Information

First Posted
February 14, 2014
Last Updated
November 18, 2015
Sponsor
Stony Brook University
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT02141386
Brief Title
Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis
Official Title
Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
National Multiple Sclerosis Society

4. Oversight

5. Study Description

Brief Summary
Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Cognitive remediation, Plasticity-based, adaptive, computerized cognitive remediation, Cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
plasticity-based, adaptive, computerized cognitive remediation (PACR)
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
Ordinary Computer Games (an "active control condition")
Intervention Type
Other
Intervention Name(s)
PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
Primary Outcome Measure Information:
Title
A composite derived from a standardized battery of neuropsychological tests
Description
Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
A timed measure based on direct observation of functional performance
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-70 Definite MS Diagnosis, any subtype [83] Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT Concurrent medications to be kept constant over three months (as possible) No relapse or steroids in previous month Reading score on WRAT-3 of 37 or greater Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff Willing to sign Agreement to Borrow Laptop Exclusion Criteria: History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment Primary psychiatric disorder that would influence ability to participate Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction) Alcohol or other substance use disorder History of computer-based training manufactured by Posit Science Learned English language after 12 years of age
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28493924
Citation
Charvet LE, Yang J, Shaw MT, Sherman K, Haider L, Xu J, Krupp LB. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177177. doi: 10.1371/journal.pone.0177177. eCollection 2017. Erratum In: PLoS One. 2018 Jan 30;13(1):e0192317.
Results Reference
derived

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Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

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