This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo. Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment. The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM. The course of medication is 6 weeks.
Matching placebo
China Rehabilitation and Research Center
Beijing, China
Buddhist Tzu Chi General Hospital, Taichung Branch
Taichung, Taiwan
Changes of Neurological Scores for Baseline
Changes of Motor Scores (0 \~ 100), Pin Prick Scores (0 \~ 112) and Light Touch Scores (0 \~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.
Time frame: 6 months
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 \~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 \~ 100, the less the better)
Time frame: 6 months
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