Multiple SclerosisNCT02141022
Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
A study testing plasticity-based computerized cognitive remediation program and Gileyna in people with Multiple Sclerosis and Cognitive Deficits, run by Stony Brook University at 1 site in United States.
Trial summary
This study is investigating the efficacy of computer-based cognitive exercises as a means of cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease modifying pharmacotherapy Gileyna. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Deficits, Gilenya Modifying Therapy for MS
- What is being tested?
- plasticity-based computerized cognitive remediation program and Gileyna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Plasticity-Based and Adaptive Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
This study is investigating the efficacy of computer-based cognitive exercises as a means of cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease modifying pharmacotherapy Gileyna.
Read the detailed description
Gilenya represents the most recent advance in MS disease-modification therapy (DMT) and shows promise for neuroprotection, a feature relevant to the progressive neurologic damage associated with the disease. Cognitive impairment accompanies MS in 40-60% of cases and when present, additional symptomatic treatment combined with DMT is required. To date no symptomatic pharmacologic therapy has shown a consistent benefit on MS associated cognitive dysfunction. However, non-pharmacologic approaches show promise. With recent technical and scientific advances, cognitive training is rapidly evolving to become the most effective intervention for the cognitive impairments associated with a wide range of neurological conditions. However, these training programs have not yet been studied in MS.
This study will be a randomized open-label clinical pilot trial to compare a plasticity-based and adaptive cognitive remediation (PACR) program to an active control (ordinary computer games) in 20 adults with multiple sclerosis (MS) starting Gilenya therapy. Primary outcome measures will be used as preliminary indicators of effect, with improvements on program task-related measures and changes in cognitive measures. Secondary outcome measures will determine the feasibility of the use of these programs in patients with MS, as indicated by compliance and patient-reported experience.
- Being tested
- plasticity-based computerized cognitive remediation program, Gileyna
- Keywords
- Multiple Sclerosis, Cognition, Cognitive Remediation, Gilenya, Computerized Cognitive Exercise
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasticity-based computerized cognitive remediation programOther
GileynaDrug
| Study group | Role | What they receive |
|---|---|---|
| PACR Program: Plasticity based, Adaptive Cognitve Remediation | Experimental | PACR Program Use: To use PACR, the participant navigates to the PACR study web site. The participant then logs into the PACR (using a study provided screen name and study identification number). A game-like experience begins, where the participant is presented with games in a set order. Each game consists of targeted exercises that contain the core science stimuli and tasks. The scheduling mechanism ensures that a participant progresses through the exercises in a defined order, generally moving from more simple (early sensory processing) exercises to more complex (multimodal, cognitive control) exercises over the course of the three-month experience. Receives: Other: plasticity-based computerized cognitive remediation program; Drug: Gileyna |
| Ordinary Computer Games | Active comparator | Active Control Program Use (Ordinary Computer Games): The active control program is composed of 13 ordinary computer games matched to the PACR condition overall. This condition is designed to be a face-valid approach to cognitive remediation. The control condition is also designed to account for nonspecific treatment effects, including placebo response, interactions with research personnel, and experience with computers and computer-related activities, and any halo or expectation effect on study assessments. Receives: Drug: Gileyna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Neuropsychological Test Results at 12weeks
Measured: 12 weeks
Secondary outcomes (1)
Evaluate the feasibility of PACR for adults with MS on Gilenya therapy who have cognitive impairment based on Participant Adherence to Study Protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Lauren Krupp, Stony Brook University
- Investigators
- Lauren Krupp, M.D., Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141022
- Sponsor's protocol ID
- CFTY720DUS26T
- Other IDs
- IIRP-1450
- Status last verified
- May 2016
- First submitted
- 14 Feb 2014
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Plasticity-Based and Adaptive Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya
- ClinicalTrials.gov ID
- NCT02141022
- Acronym / sponsor ID
- CFTY720DUS26T
- Keywords
- Multiple Sclerosis, Cognition, Cognitive Remediation, Gilenya, Computerized Cognitive Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating the efficacy of computer-based cognitive exercises as a means of cognitive remediation in patients with Multiple Sclerosis (MS) who are beginning the disease modifying pharmacotherapy Gileyna.
Detailed description
Gilenya represents the most recent advance in MS disease-modification therapy (DMT) and shows promise for neuroprotection, a feature relevant to the progressive neurologic damage associated with the disease. Cognitive impairment accompanies MS in 40-60% of cases and when present, additional symptomatic treatment combined with DMT is required. To date no symptomatic pharmacologic therapy has shown a consistent benefit on MS associated cognitive dysfunction. However, non-pharmacologic approaches show promise. With recent technical and scientific advances, cognitive training is rapidly evolving to become the most effective intervention for the cognitive impairments associated with a wide range of neurological conditions. However, these training programs have not yet been studied in MS.
This study will be a randomized open-label clinical pilot trial to compare a plasticity-based and adaptive cognitive remediation (PACR) program to an active control (ordinary computer games) in 20 adults with multiple sclerosis (MS) starting Gilenya therapy. Primary outcome measures will be used as preliminary indicators of effect, with improvements on program task-related measures and changes in cognitive measures. Secondary outcome measures will determine the feasibility of the use of these programs in patients with MS, as indicated by compliance and patient-reported experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACR Program: Plasticity based, Adaptive Cognitve Remediation | Experimental | Other: plasticity-based computerized cognitive remediation program, Drug: GileynaPACR Program Use: To use PACR, the participant navigates to the PACR study web site. The participant then logs into the PACR (using a study provided screen name and study identification number). A game-like experience begins, where the participant is presented with games in a set order. Each game consists of targeted exercises that contain the core science stimuli and tasks. The scheduling mechanism ensures that a participant progresses through the exercises in a defined order, generally moving from more simple (early sensory processing) exercises to more complex (multimodal, cognitive control) exercises over the course of the three-month experience. |
| Ordinary Computer Games | Active comparator | Drug: GileynaActive Control Program Use (Ordinary Computer Games): The active control program is composed of 13 ordinary computer games matched to the PACR condition overall. This condition is designed to be a face-valid approach to cognitive remediation. The control condition is also designed to account for nonspecific treatment effects, including placebo response, interactions with research personnel, and experience with computers and computer-related activities, and any halo or expectation effect on study assessments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasticity-based computerized cognitive remediation program | Other | PACR Program: Plasticity based, Adaptive Cognitve Remediation |
| Gileyna | Drug | Ordinary Computer Games, PACR Program: Plasticity based, Adaptive Cognitve Remediation |
Primary outcome
Change from Baseline in Neuropsychological Test Results at 12weeks
Time frame: 12 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Krupp, M.D. principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasticity-based computerized cognitive remediation program and Gileyna in people with Multiple Sclerosis and Cognitive Deficits, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Neuropsychological Test Results at 12weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.