Multiple SclerosisNCT02141386
Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis
A study testing PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) in people with Multiple Sclerosis, run by Stony Brook University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
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.
- Conditions
- Multiple Sclerosis
- Being tested
- PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)
- Keywords
- Multiple Sclerosis, Cognitive remediation, Plasticity-based, adaptive, computerized cognitive remediation, Cognitive impairment
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)Other
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | plasticity-based, adaptive, computerized cognitive remediation (PACR) Receives: Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) |
| Treatment B | Active comparator | Ordinary Computer Games (an "active control condition") Receives: Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12weeks
Secondary outcomes (1)
A timed measure based on direct observation of functional performance
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 posted19 May 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Lauren Krupp, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141386
- Sponsor's protocol ID
- RG4808A81
- Status last verified
- Nov 2015
- First submitted
- 14 Feb 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
Publications
Charvet LE, Yang J, Shaw MT, Sherman K, Haider L, Xu J, Krupp LB. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177177. doi: 10.1371/journal.pone.0177177. eCollection 2017.
PubMed 28493924
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity-based, Adaptive, Computerized Cognitive Remediation Treatment (PACR) for Adults With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT02141386
- Acronym / sponsor ID
- RG4808A81
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive remediation, Plasticity-based, adaptive, computerized cognitive remediation, Cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- First posted
- 19 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)plasticity-based, adaptive, computerized cognitive remediation (PACR) |
| Treatment B | Active comparator | Other: PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)Ordinary Computer Games (an "active control condition") |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) | Other | Treatment A, Treatment B |
Primary outcome
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
1 secondary outcome
A timed measure based on direct observation of functional performance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 28493924Charvet LE, Yang J, Shaw MT, Sherman K, Haider L, Xu J, Krupp LB. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177177. doi: 10.1371/journal.pone.0177177. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation) in people with Multiple Sclerosis, 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 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. 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?
Results are not available in the source record.
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?
A composite derived from a standardized battery of neuropsychological tests (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141386, which also lists 1 linked publication.
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 20 Nov 2015.