This trial is active, not recruiting.

Condition multiple sclerosis
Treatment pacr (plasticity-based, adaptive, computerized cognitive remediation)
Sponsor Stony Brook University
Collaborator National Multiple Sclerosis Society (NMSS)
Start date September 2013
End date September 2015
Trial size 136 participants
Trial identifier NCT02141386, RG4808A81


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
plasticity-based, adaptive, computerized cognitive remediation (PACR)
pacr (plasticity-based, adaptive, computerized cognitive remediation)
(Active Comparator)
Ordinary Computer Games (an "active control condition")
pacr (plasticity-based, adaptive, computerized cognitive remediation)

Primary Outcomes

A composite derived from a standardized battery of neuropsychological tests
time frame: 12weeks

Secondary Outcomes

A timed measure based on direct observation of functional performance
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Stony Brook University.