Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
NCT ID: NCT00220493
Last Updated: 2007-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2003-06-30
2005-06-30
Brief Summary
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Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade.
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Detailed Description
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Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade. Cognitive impairments occur frequently (43 to 65%) in MS. Moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. Even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living.
We have recently reported that cognitive impairment occurred in 53.7% of patients with probable MS (evaluated within a mean of one month of the onset of new neurological symptoms). Verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). An additional study demonstrated that MS patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. This high rate of attention impairment found in MS patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. Consequently, we suggest investigating whether treatment with Ritalin (methylphenidate) has an effect on patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
ECT
DOUBLE
Interventions
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Ritalin
Eligibility Criteria
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Inclusion Criteria
* Attention impairment defined as abnormal PASAT score;
* Written and signed informed consent;
Exclusion Criteria
* Steroid treatment;
* Persistent psychostimulant treatment;
* MS relapse;
25 Years
65 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Principal Investigators
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Anat Achiron, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sackler School of Medicine
Yirmiyahu Harel, MD
Role: PRINCIPAL_INVESTIGATOR
Sachler School of Medicine
Nava Appleboim-Gavish, MA
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center at Tel Hashomer Israel
Locations
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Multiple Sclerosis Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Other Identifiers
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SHEBA-03-2966-AA-CTIL
Identifier Type: -
Identifier Source: org_study_id
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