Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury
Brief summary
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.
Interventions
DRUGLithium 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.
DRUGPlacebo
Matching placebo
Sponsors
China Rehabilitation Research Center
Buddhist Tzu Chi General Hospital
China Spinal Cord Injury Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Neurological Scores for Baseline | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | 6 months | 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) |
Countries
China, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo: Matching placebo | 20 |
| Lithium Carbonate Lithium Carbonate
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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Lithium Carbonate | Total |
|---|---|---|---|
| Age, Continuous | 38.05 Year STANDARD_DEVIATION 10.092 | 41.4 Year STANDARD_DEVIATION 6.785 | 39.624 Year STANDARD_DEVIATION 8.617 |
| Age, Customized 18-30 years-old | 4 participants | 1 participants | 5 participants |
| Age, Customized 31-40 years-old | 9 participants | 8 participants | 17 participants |
| Age, Customized 41-50 years-old | 4 participants | 10 participants | 14 participants |
| Age, Customized 51-60 years-old | 3 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 20 | 16 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes of Neurological Scores for Baseline | change light touch score (wk6-d0) | -0.158 units on a scale | Standard Deviation 0.688 |
| Placebo | Changes of Neurological Scores for Baseline | change light touch score (m6-d0) | 2.208 units on a scale | Standard Deviation 7.141 |
| Placebo | Changes of Neurological Scores for Baseline | change pin-prick score (wk6-d0) | 0.053 units on a scale | Standard Deviation 0.229 |
| Placebo | Changes of Neurological Scores for Baseline | change pin-prick score (m6-d0) | 1.906 units on a scale | Standard Deviation 6.775 |
| Placebo | Changes of Neurological Scores for Baseline | change motor score (wk6-d0) | -1 units on a scale | Standard Deviation 4.607 |
| Placebo | Changes of Neurological Scores for Baseline | change motor score (m6-d0) | 0.844 units on a scale | Standard Deviation 6.471 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change motor score (wk6-d0) | 0 units on a scale | Standard Deviation 0 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change light touch score (wk6-d0) | 0 units on a scale | Standard Deviation 0 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change pin-prick score (m6-d0) | -0.982 units on a scale | Standard Deviation 6.498 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change light touch score (m6-d0) | -0.766 units on a scale | Standard Deviation 6.014 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change motor score (m6-d0) | 1.316 units on a scale | Standard Deviation 2.657 |
| Lithium Carbonate | Changes of Neurological Scores for Baseline | change pin-prick score (wk6-d0) | 0.053 units on a scale | Standard Deviation 0.229 |
Comparison: change light touch score (wk6-d0)p-value: 0.343Wilcoxon (Mann-Whitney)
Comparison: change light touch score (m6-d0)p-value: 0.69Wilcoxon (Mann-Whitney)
Comparison: change pin-prick score (wk6-d0)p-value: 1Wilcoxon (Mann-Whitney)
Comparison: change pin-prick score (m6-d0)p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: change motor score (wk6-d0)p-value: 1Wilcoxon (Mann-Whitney)
Comparison: change motor score (m6-d0)p-value: 0.582Wilcoxon (Mann-Whitney)
Secondary
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in FIM (Wk6 - D0) | 0.2 units on a scale | Standard Deviation 0.4 |
| Placebo | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in FIM (M6 - D0) | 3.5 units on a scale | Standard Deviation 7.3 |
| Placebo | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in VAS (Wk6 - D0) | 1.0 units on a scale | Standard Deviation 4 |
| Placebo | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in VAS (M6 - D0) | -0.9 units on a scale | Standard Deviation 17.1 |
| Lithium Carbonate | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in VAS (M6 - D0) | -9.3 units on a scale | Standard Deviation 15.3 |
| Lithium Carbonate | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in FIM (Wk6 - D0) | -0.3 units on a scale | Standard Deviation 1.6 |
| Lithium Carbonate | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in VAS (Wk6 - D0) | -9.3 units on a scale | Standard Deviation 16.6 |
| Lithium Carbonate | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | change in FIM (M6 - D0) | 0.04 units on a scale | Standard Deviation 5.4 |
Comparison: FIM change (Wk6 - D0)p-value: 0.257Wilcoxon (Mann-Whitney)
Comparison: FIM change (M6 - D0)p-value: 0.168Wilcoxon (Mann-Whitney)
Comparison: VAS change (Wk6 - D0)p-value: 0.013Wilcoxon (Mann-Whitney)
Comparison: VAS change (M6 - D0)p-value: 0.137Wilcoxon (Mann-Whitney)