Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02141386
• Other study ID #: RG4808A81
• Status: Active, not recruiting
• Phase: N/A
• First received: February 14, 2014
• Last updated: November 18, 2015
• Start date: September 2013

Study information

• Verified date: November 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	National Multiple Sclerosis Society (NMSS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite derived from a standardized battery of neuropsychological tests	Covariates will include baseline cognitive status, PACR program compliance, PACR task improvement, and participant-reported outcomes	12weeks
Secondary	A timed measure based on direct observation of functional performance		12 weeks