Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02141022
• Date of registration: 14/02/2014
• Prospective Registration: No
• Primary sponsor: Stony Brook University
• Public title: Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
• Scientific title: A Pilot Study of Plasticity-Based and Adaptive Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
• Date of first enrolment: August 2013
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02141022
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Lauren Krupp, M.D.
• Affiliation: Stony Brook University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ages 18-70

- Relapsing Remitting MS Diagnosis [81]

- Initiating Gilenya therapy, or current Gilenya therapy (kept constant for the past
one month)

- 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.

Exclusion Criteria:

- Previous trial of Gilenya therapy

- History of mental retardation, pervasive developmental disorder or other neurological
condition associated with cognitive impairment

- Primary psychiatric disorder or unstable medical disorder that would influence
ability to participate

- History of computer-based training with procedures similar to those proposed

- Learned English language after 12 years of age

- Unable to comply with study procedures



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cognitive Deficits

Multiple Sclerosis

Gilenya Modifying Therapy for MS

Intervention(s)

Other: plasticity-based computerized cognitive remediation program

Drug: Gileyna

Primary Outcome(s)

Change from Baseline in Neuropsychological Test Results at 12weeks [Time Frame: 12 weeks]

Secondary Outcome(s)

Evaluate the feasibility of PACR for adults with MS on Gilenya therapy who have cognitive impairment based on Participant Adherence to Study Protocol [Time Frame: 12 weeks]

Secondary ID(s)

CFTY720DUS26T

IIRP-1450

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis