Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

• Registration Number: NCT02141386
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-19
• Primary Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)	Ordinary Computer Games (an "active control condition")
Treatment A	PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)	plasticity-based, adaptive, computerized cognitive remediation (PACR)

Primary Outcome Measures

Name	Time	Method
A composite derived from a standardized battery of neuropsychological tests	12weeks	Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes

Secondary Outcome Measures

Name	Time	Method
A timed measure based on direct observation of functional performance	12 weeks

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States