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Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

NCT ID: NCT02141386

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Treatment B

Ordinary Computer Games (an "active control condition")

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Lauren Krupp

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28493924 (View on PubMed)

Other Identifiers

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RG4808A81

Identifier Type: -

Identifier Source: org_study_id