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Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

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Stony Brook University

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02141386
RG4808A81

Details and patient eligibility

About

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.

Enrollment

136 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

136 participants in 2 patient groups

Treatment A
Experimental group
Description:
plasticity-based, adaptive, computerized cognitive remediation (PACR)
Treatment:
Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
Treatment B
Active Comparator group
Description:
Ordinary Computer Games (an "active control condition")
Treatment:
Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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