Effectiveness and Safety of tDCS for Pain

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612165
• Other study ID #: 03-2022-001
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Pusan National University Yangsan Hospital
• Contact: JISOO BAIK
• Phone: +82553604159
• Email: zisoo[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Adults aged 19 to 90 years old

2. Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis

3. A person whose stroke lesions are cortex or subcortex

4. A person who satisfies 'Mandatory criteria'

5. Those with cognitive ability to understand and follow the researcher's instructions

6. Those who voluntarily agree to participate in this clinical trial and signed the agreement

Exclusion Criteria:

1. Those who have a fracture or have undergone orthopedic surgery

2. In case of accompanying serious neurological diseases

3. In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia

4. Those with complex part pain syndrome by Budapest Criteria

5. If there is a cause of other pain in the relevant area, such as peripheral nerve damage

6. Persons included in the exclusion of transcranial direct current stimulation

7. If the researcher is judged to be judged that the participation in this study is not appropriate

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Device:
• Transcranial Direct Current Stimulation(tDCS)
The tDCS intervention was conducted for 20 minutes(1000µA) each time, 5 times a week for 2 weeks, a total of 10 times.
• Sham Transcranial Direct Current Stimulation(sham tDCS)
The sham tDCS intervention was conducted for 20 minutes(0µA) each time, 5 times a week for 2 weeks, a total of 10 times.

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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