Effectiveness and Safety of tDCS for Pain

Study Overview
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Brief Summary
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The purpose of this study is to verify the effectiveness and safty of transcranial direct current stimulation in patients with central post-stroke pain.

Official Title
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Effectiveness and Safety of Transcranial Direct Current Stimulation for Pain Changes in Patients With Central Post-Stroke Pain

Conditions
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Pain, Chronic

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation(tDCS)
* Device: Sham Transcranial Direct Current Stimulation(sham tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 to 90 years old Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis A person whose stroke lesions are cortex or subcortex A person who satisfies 'Mandatory criteria' Those with cognitive ability to understand and follow the researcher's instructions Those who voluntarily agree to participate in this clinical trial and signed the agreement Exclusion Criteria: Those who have a fracture or have undergone orthopedic surgery In case of accompanying serious neurological diseases In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia Those with complex part pain syndrome by Budapest Criteria If there is a cause of other pain in the relevant area, such as peripheral nerve damage Persons included in the exclusion of transcranial direct current stimulation If the researcher is judged to be judged that the participation in this study is not appropriate

Ages Eligible for Study
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Minimum Age: 19 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS group<br> | Device: Transcranial Direct Current Stimulation(tDCS)<br>* The tDCS intervention was conducted for 20 minutes(1000μA) each time, 5 times a week for 2 weeks, a total of 10 times.<br>|
| Sham Comparator: Control group<br> | Device: Sham Transcranial Direct Current Stimulation(sham tDCS)<br>* The sham tDCS intervention was conducted for 20 minutes(0μA) each time, 5 times a week for 2 weeks, a total of 10 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain score in Brief Pain Inventory(BPI) | Brief Pain Inventory(BPI) is used for measurement. | Baseline, after 2 weeks, and 1 month after the end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain score in Neuropathic Pain Scale(NPS) | Neuropathic Pain Scale(NPS) is used for measurement. | Baseline, after 2 weeks, and 1 month after the end of intervention | 
| Change of depression score in Beck Depression Inventory-II(BDI-II) | Beck Depression Inventory-II(BDI-II) is used for measurement. | Baseline, after 2 weeks, and 1 month after the end of intervention | 
| Change of quality of life score in EQ-5D-3L | EQ-5D-3L is used for measurement. | Baseline, after 2 weeks, and 1 month after the end of intervention |