Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
Scientific background:
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.
Scientific background:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
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