Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients

Sheba Medical Center

Status and phase: Unknown; Phase 1

Conditions: Relapsing Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Treatments: Drug: Ritalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00220493

SHEBA-03-2966-AA-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Educational/Counseling/Training

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind