Effectiveness and Safety of tDCS for Pain

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Device: Sham Transcranial Direct Current Stimulation(sham tDCS); Device: Transcranial Direct Current Stimulation(tDCS)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan
    • Gyeongsang, Yangsan, Korea, Republic of, 50610
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group	Device: 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.
Experimental: tDCS group	Device: Transcranial Direct Current Stimulation(tDCS); The tDCS intervention was conducted for 20 minutes(2000μA) each time, 5 times a week for 2 weeks, a total of 10 times.

What is the study measuring?

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. The Brief Pain Inventory (BPI) is a tool used to assess pain severity and its impact on daily functions. The BPI typically uses an 11-point numeric rating scale (NRS) for its pain severity and pain interference items. Each item is rated from 0 to 10. Pain Severity: 0 (no pain) to 10 (pain as bad as you can imagine). Pain Interference: 0 (does not interfere) to 10 (completely interferes).	Baseline, after 2 weeks(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. The Neuropathic Pain Scale (NPS) is a tool used to assess the various qualities and intensities of neuropathic pain. Each Item: 0 (no pain or absence of the described pain quality) to 10 (the most intense pain or presence of the described pain quality imaginable).	Baseline, after 2 weeks(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. The Beck Depression Inventory-II (BDI-II) is a widely used instrument for measuring the severity of depression. Minimum and Maximum Values: The BDI-II consists of 21 items, each rated on a 4-point scale ranging from 0 to 3. Total Score Range: 0 to 63. Each Item: 0 (symptom is absent) to 3 (severe level of the symptom).	Baseline, after 2 weeks(after the end of intervention)
Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)	The EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L) is used for measurement. The EuroQol Five-Dimensions-Three-Level Quality of Life Instrument (EQ-5D-3L) is a standardized instrument used to measure health-related quality of life. This utility score reflects the overall quality of life associated with each health state and typically ranges from -0.594 to 1 in the UK: A value closer to 1 indicates a better health state.	Baseline, after 2 weeks(after the end of intervention)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 03-2022-001

Drug and device information, study documents

• 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