The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.

Detailed Description
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Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.

Official Title
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The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study

Conditions
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Neuropathic Pain, Spinal Cord Injury

Intervention / Treatment
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* Device: tsDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90 neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months) informed consent Exclusion Criteria: patients with any clinically significant or unstable medical or progressive neurologic disorder contraindication for electrial stimulation such as pacemaker implant Women of childbearing age or pregnancy significant cognitive deficit Syringomyelia neuropsychiatric comorbidity depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory) history of substance abuse skin defect under the electrodes progressive neurological disease or other secondary conditions that could impact neuropathic pain

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Crossover Assignment
Interventional Model Description: tsDCS
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tsDCS<br>In the tsDCS group, anodal tsDCS will be applied for 20 minutes. | Device: tsDCS<br>* Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.<br>* Other names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany);|
| Placebo Comparator: sham<br>In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes. | Device: tsDCS<br>* Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.<br>* Other names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) for neuropathic pain | On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable | Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment (PGA) | One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective Markedly improved Moderately improved Mildly improved No change Mildly worse Moderately worse Markedly worse | Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation | 
| Present Pain Intensity (PPI) | Patient's subjective feeling of the intensity of pain right now 0: No pain Mild Discomforting Distressing Excruciating Horrible | Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation |