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Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141386
Recruitment Status : Unknown
Verified November 2015 by Lauren Krupp, Stony Brook University.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2014
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
National Multiple Sclerosis Society (NMSS)
Information provided by (Responsible Party):
Lauren Krupp, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
Study Start Date : September 2013
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. A composite derived from a standardized battery of neuropsychological tests [ Time Frame: 12weeks ]
    Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes


Secondary Outcome Measures :
  1. A timed measure based on direct observation of functional performance [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141386


Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
National Multiple Sclerosis Society (NMSS)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lauren Krupp, Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT02141386    
Other Study ID Numbers: RG4808A81
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Lauren Krupp, Stony Brook University:
Multiple Sclerosis
Cognitive remediation
Plasticity-based, adaptive, computerized cognitive remediation
Cognitive impairment
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases