NCT02141386

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.

Trial Health

55
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Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

February 14, 2014

Last Update Submit

November 18, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCognitive remediationPlasticity-based, adaptive, computerized cognitive remediationCognitive impairment

Outcome Measures

Primary Outcomes (1)

  • 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

    12weeks

Secondary Outcomes (1)

  • A timed measure based on direct observation of functional performance

    12 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

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

Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

Treatment B

ACTIVE COMPARATOR

Ordinary Computer Games (an "active control condition")

Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

Interventions

PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)OTHER
Treatment ATreatment B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • 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.

    PMID: 28493924DERIVED

MeSH Terms

Conditions

Multiple SclerosisCognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

February 14, 2014

First Posted

May 19, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(1)