Clinical trial NCT00220493: Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients
Official title: Clinical Study Protocol: Evaluation of the Efficiency of Ritalin in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Keywords: MS
RITALIN
PASAT
COGNITION
ATTENTION
Relapsing remitting
Secondary progressive
Primary progressive
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of definite MS according to Poser criteria;
* Attention impairment defined as abnormal PASAT score;
* Written and signed informed consent;

Exclusion Criteria:

* Pregnancy or lactation;
* Steroid treatment;
* Persistent psychostimulant treatment;
* MS relapse;

Primary outcomes:
measure: Score on the Paced Auditory Serial Addition Test (PASAT) one hour after taking the drug/placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Multiple Sclerosis Center
Study officials:
affiliation: Sackler School of Medicine
name: Anat Achiron, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sachler School of Medicine
name: Yirmiyahu Harel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center at Tel Hashomer Israel
name: Nava Appleboim-Gavish, MA
role: PRINCIPAL_INVESTIGATOR
References: