Back to resultsEffectiveness and Safety of tDCS for Pain
Primary Purpose
Pain, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation(tDCS)
Sham Transcranial Direct Current Stimulation(sham tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
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
Sites / Locations
- Pusan national university Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Change of pain score in Brief Pain Inventory(BPI)
Brief Pain Inventory(BPI) is used for measurement.
Secondary Outcome Measures
Change of pain score in Neuropathic Pain Scale(NPS)
Neuropathic Pain Scale(NPS) is used for measurement.
Change of depression score in Beck Depression Inventory-II(BDI-II)
Beck Depression Inventory-II(BDI-II) is used for measurement.
Change of quality of life score in EQ-5D-3L
EQ-5D-3L is used for measurement.
Full Information
NCT ID
NCT05612165
First Posted
November 3, 2022
Last Updated
November 3, 2022
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05612165
Brief Title
Effectiveness and Safety of tDCS for Pain
Official Title
Effectiveness and Safety of Transcranial Direct Current Stimulation for Pain Changes in Patients With Central Post-Stroke Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation(tDCS)
Intervention Description
The tDCS intervention was conducted for 20 minutes(1000μA) each time, 5 times a week for 2 weeks, a total of 10 times.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation(sham tDCS)
Intervention Description
The sham tDCS intervention was conducted for 20 minutes(0μA) each time, 5 times a week for 2 weeks, a total of 10 times.
Primary Outcome Measure Information:
Title
Change of pain score in Brief Pain Inventory(BPI)
Description
Brief Pain Inventory(BPI) is used for measurement.
Time Frame
Baseline, after 2 weeks, and 1 month after the end of intervention
Secondary Outcome Measure Information:
Title
Change of pain score in Neuropathic Pain Scale(NPS)
Description
Neuropathic Pain Scale(NPS) is used for measurement.
Time Frame
Baseline, after 2 weeks, and 1 month after the end of intervention
Title
Change of depression score in Beck Depression Inventory-II(BDI-II)
Description
Beck Depression Inventory-II(BDI-II) is used for measurement.
Time Frame
Baseline, after 2 weeks, and 1 month after the end of intervention
Title
Change of quality of life score in EQ-5D-3L
Description
EQ-5D-3L is used for measurement.
Time Frame
Baseline, after 2 weeks, and 1 month after the end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JISOO BAIK
Phone
+82553604159
Email
zisoo@pusan.ac.kr
Facility Information:
Facility Name
Pusan national university Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan
ZIP/Postal Code
50610
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youjin Jeong
Email
ctccrc@pnuyh.co.kr
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of tDCS for Pain
We'll reach out to this number within 24 hrs