Clinical trial NCT02141386: Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis
Official title: Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cognitive remediation
Plasticity-based, adaptive, computerized cognitive remediation
Cognitive impairment
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2014-05-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: A composite derived from a standardized battery of neuropsychological tests
timeFrame: 12weeks
Secondary outcomes:
measure: A timed measure based on direct observation of functional performance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
References:
citation: 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.