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Completed

NCT Number: NCT05612165

Effectiveness and Safety of tDCS for 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.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation(tDCS)

Device

The tDCS intervention was conducted for 20 minutes(2000μA) each time, 5 times a week for 2 weeks, a total of 10 times.

Sham Transcranial Direct Current Stimulation(sham tDCS)

Device

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 outcomes

  1. Change of pain score in Brief Pain Inventory(BPI)

    Time frame: Baseline, after 2 weeks(after the end of intervention)

    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).

Secondary outcomes

  1. Change of pain score in Neuropathic Pain Scale(NPS)

    Time frame: Baseline, after 2 weeks(after the end of intervention)

    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).

  2. Change of depression score in Beck Depression Inventory-II(BDI-II)

    Time frame: Baseline, after 2 weeks(after the end of intervention)

    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).

  3. Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)

    Time frame: Baseline, after 2 weeks(after the end of intervention)

    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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 10, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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