Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
A composite derived from a standardized battery of neuropsychological tests
time frame: 12weeks
A timed measure based on direct observation of functional performance
time frame: 12 weeks
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Ages 18-70 - Definite MS Diagnosis, any subtype  - 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
|Official title||Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)|
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