Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial|
- Changes of Neurological Scores for Baseline [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
- Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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)
|Study Start Date:||August 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Experimental: Lithium carbonate
Lithium Carbonate tablet, 250mg
Drug: Lithium Carbonate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750061
|China Rehabilitation and Research Center|
|Buddhist Tzu Chi General Hospital, Taichung Branch|
|Principal Investigator:||Mingliang Yang, MD, Ph.D||China Rehabilitation and Research Center|
|Principal Investigator:||Tzu-Yung Chen, MD||Buddhist Tzu Chi General Hospita, Taichung Branch|