Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

Inclusion Criteria:

• Subjects of either gender and 18-60 years of age;
• Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer);
• Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;
• Spinal cord injury vertebral level should be between C4 and T10;
• Subjects must be able to read, understand, and complete the VAS;
• Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures.

Exclusion Criteria:

• A history of hypersensitivity or other adverse reaction to lithium;
• Significant renal, cardiovascular, hepatic and psychiatric disease;
• Significant medical diseases or infection;
• Addison's disease;
• Debilitation or dehydration;
• Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;
• A history of alcohol abuse or drug abuse;
• Pregnant or lactating women;
• Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;
• Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study;
• Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally;
• Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.