Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain

Study Overview
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Brief Summary
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To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.

Detailed Description
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This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured subjects with neuropathic pain will be randomized into two groups. The subject in the Treatment Group will receive lithium carbonate tablet, while the Control Group will receive placebo tablet. Neither the subjects nor the physicians know which group the subjects are allocated. Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment Group, the dose will be adjusted according to the serum lithium level. While in the Control Group, the dose will be adjusted based on the dummy serum level report. The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a phone call follow-up at 24 weeks from the start of the medication. The primary outcome measure is the severity level of pain. The efficacy and safety will be analyzed by comparing the results of the Treatment Group with those of the Control Group

Official Title
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Double Blind, Randomized Placebo-controlled Clinical Study Evaluating the Efficacy of Lithium Carbonate in the Treatment of Neuropathic Pain of Patients With Spinal Cord Injury

Conditions
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Neuropathic Pain, Neuralgia, Spinal Cord Injuries

Intervention / Treatment
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* Drug: Lithium Carbonate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65; Diagnosis of traumatic spinal cord injury; Clinically diagnosed neuropathic pain; Pain severity is at least 4 on a 11-point numeric rating scale at screening; Pain present regularly for at least 6 weeks before enrollment; Able to understand instructions and provide reliable pain assessments; Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form; Exclusion Criteria: Significant renal, cardiovascular, hepatic, infectious or psychiatric disease; Significant brain injury with neurological deficits; Debilitation or dehydration; Addison's disease; Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines; A history of substance or alcohol abuse within past 1 year; A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period; Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control; Participation in any drug study in the last three months; History of oral lithium intake for any reason; or any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium treatment group<br>Lithium carbonate, 250mg/tablet. The dose starts with three times a day and one tablet each time for a week. The daily dose will then be adjusted according to serum lithium level and clinical finding. Target serum lithium level is 0.6 - 1.2mmol/L. | Drug: Lithium Carbonate<br>* 250 mg/tablet, 6 weeks course of oral administration<br>|
| Placebo Comparator: Control group<br>The dose of the placebo will be adjusted according to the dummy serum level report. | Drug: Placebo<br>* placebo tablet, 6 week course of oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks | pain severity level | D0, Wk 1, 2, 6, 12, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS) |  | D0, Wk 1, 2, 6, 12 and 24 | 
| Change in Short-Form 36 single question |  | D0, Wk 1, 2, 6, 12, and 24 | 
| Change in Sleep Interference Assessment score |  | D0, Wk 1, 2, 6, 12 and 24 | 
| Change in weekly number of days with pain attack |  | D0, Wk 1, 2, 6, 12 and 24 | 
| Change in the Patient Global Impression of Change (PGIC) |  | Wk 1, 2, 6, and 12 | 
| Change in Patient Health Questionnaire (PHQ-9) |  | D0, Wk 1, 2, 6 and 12 | 
| Change in sensory score, motor score and ASIA impairment (AIS) scale |  | D0, Wk 6 and 12 | 
| Change in Modified Ashworth Scale |  | D0, Wk 6 and 12 | 
| Magnetic resonance diffusion tensor imaging (optional) |  | D0, Wk 6 and 12 | 
| Electrophysiology (optional) |  | D0, Wk 6 and 12 |