Multiple SclerosisNCT01303770
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
A study testing Self-management cognitive rehabilitation group intervention in people with Multiple Sclerosis and Cognitive Impairment, run by Tel Aviv University at 1 site in Israel.
Trial summary
Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment
- What is being tested?
- Self-management cognitive rehabilitation group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS
- 18 years of age or older
- Self-report of cognitive difficulties
Who cannot join
- Exacerbation of symptoms in past 3 months
- History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center, Multiple Sclerosis Clinic
Petah Tikva, 49100
About this study
Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.
Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.
The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Being tested
- Self-management cognitive rehabilitation group intervention, Control intervention
- Keywords
- Multiple Sclerosis, Cognitive impairment, Self-management programs, Occupational Therapy, Rehabilitation
- 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.
Self-management cognitive rehabilitation group interventionBehavioural
8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.
Control interventionBehavioural
8-week group program that is not specifically directed to management of cognitive impairments.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive intervention group | Experimental | Cognitive rehabilitation program designed to be tested in this study Receives: Behavioral: Self-management cognitive rehabilitation group intervention |
| Control group | Active comparator | Not described Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive strategy use
Measured: pre intervention, post intervention, 3,6,12 month followup
Secondary outcomes (1)
Cognitive self-efficacy
Measured: pre-intervention, post intervention, 3,6,12 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eynat Shevil, Tel Aviv University
- Investigators
- Eynat Shevil, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303770
- Sponsor's protocol ID
- MSCogRehab
- Other IDs
- PIRG03-GA-2008-230959
- Status last verified
- Dec 2013
- First submitted
- 24 Feb 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01303770
- Acronym / sponsor ID
- MSCogRehab
- Conditions
- Multiple Sclerosis, Cognitive Impairment
- Keywords
- Multiple Sclerosis, Cognitive impairment, Self-management programs, Occupational Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Feb 2011 (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.
Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.
Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.
The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive intervention group | Experimental | Behavioral: Self-management cognitive rehabilitation group interventionCognitive rehabilitation program designed to be tested in this study |
| Control group | Active comparator | Behavioral: Control intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of MS
- 18 years of age or older
- Self-report of cognitive difficulties
Key exclusion criteria (2 listed)
- Exacerbation of symptoms in past 3 months
- History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse
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 |
|---|---|---|
| Self-management cognitive rehabilitation group intervention8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies. | Behavioural | Cognitive intervention group |
| Control intervention8-week group program that is not specifically directed to management of cognitive impairments. | Behavioural | Control group |
Primary outcome
Cognitive strategy use
Time frame: pre intervention, post intervention, 3,6,12 month followup
1 secondary outcome
Cognitive self-efficacy
Time frame: pre-intervention, post intervention, 3,6,12 month followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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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.
Eynat Shevil, PhD principal investigator
Tel Aviv 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 Self-management cognitive rehabilitation group intervention in people with Multiple Sclerosis and Cognitive Impairment, run by Tel Aviv University at 1 site in Israel.
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 3 inclusion and 2 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 25 Dec 2013. 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 Israel. 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?
Cognitive strategy use (time frame: pre intervention, post intervention, 3,6,12 month followup). 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 25 Dec 2013.