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NCT Number: NCT06740591

HD-tDCS for Pain Reduction in Post-Stroke Pain: a Randomized Crossover Trial

This study aims to assess the effectiveness of multichannel transcranial direct current stimulation (tDCS) in alleviating pain and to evaluate its safety in patients with central post-stroke pain (CPSP)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke Brain Diseases CPSP Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases tDCS

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 between 19 and 90 years.
  • Diagnosed with first-ever stroke based on clinical observation and neuroimaging by a physician.
  • Stroke lesion located in the cortex or subcortex [basal ganglia (BG) or thalamus].
  • Fulfillment of mandatory criteria for pain (pain in the body part corresponding to central nervous system lesions, onset of pain immediately after stroke, confirmation that the pain corresponds to the lesion site, exclusion of other causes of pain such as peripheral neuropathic pain).
  • Cognitive ability sufficient to understand and follow the instructions of the researcher.
  • Voluntary consent to participate in the clinical trial and signed informed consent.

Exclusion criteria

  • History of fractures or orthopedic surgeries on the affected side.
  • Presence of significant pre-existing neurogenic disorders.
  • Co-existing severe psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
  • Complex regional pain syndrome (CRPS) diagnosed based on Budapest criteria.
  • Other causes of pain in the affected area, such as peripheral nerve damage.
  • Exclusion criteria for transcranial magnetic stimulation (e.g., pregnancy, cancer, patients with abnormal responses to stimulation, presence of intracranial metal implants, hypersensitivity to pain, history of seizures, or injuries/skin conditions at electrode attachment sites).
  • Deemed unsuitable for participation in the study by the principal investigator.

Treatment and study plan

HD-tDCS

Device

The HD-tDCS stimulation was applied for 20 minutes, 5 times a week, for a total of 10 sessions.

Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS)

Device

The Sham HD-tDCS stimulation was applied for 20 minutes, 5 times a week, for a total of 10 sessions.

Primary outcomes

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

    Time frame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)

    The Brief Pain Inventory (BPI) is a widely used questionnaire for assessing pain. It measures pain intensity over the past week or the last 24 hours using four 11-point Likert scale items: worst pain, least pain, average pain, and current pain. Additionally, it evaluates how pain interferes with daily activities, mood, walking ability, normal work, relationships with others, sleep, and leisure activities, also using an 11-point Likert scale. The total score ranges from 0 (no pain) to 40 (worst pain), with higher scores indicating greater musculoskeletal pain severity. Pain intensity is categorized as mild (1-4), moderate (5-6), or severe (7-10).

Secondary outcomes

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

    Time frame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)

    The Neuropathic Pain Scale (NPS) consists of 10 subscales, each representing a different aspect of neuropathic pain. Pain intensity for each subscale is measured using a Visual Analog Scale (VAS), where 0 indicates no pain and 10 represents the worst possible pain. These subscales assess the intensity of overall pain, sharpness, heat, aching, cold, sensitivity to light touch or fabric, and itchiness. Participants complete this assessment through an interview-based questionnaire. Higher scores reflect greater pain intensity.

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

    Time frame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)

    The Beck Depression Inventory (BDI) is one of the most widely used depression assessment tools worldwide. The BDI consists of questions based on common daily life experiences . As a self-report tool, participants complete the questionnaire by indicating which statements apply to them. The inventory includes 21 items, each with four response options, scored from 0 to 3, with a total possible score of 63. Higher scores indicate a greater severity of depression.

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

    Time frame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)

    This tool is widely used to assess health-related quality of life. It consists of three multiple-choice questions across five domains: mobility (M), self-care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD). Responses are coded on a scale from 1 to 3, representing none, moderate, and severe, respectively. The total score ranges from 1 (no problems in any domain) to 3 (severe problems in all domains). Higher scores indicate a lower quality of life.

  4. Change in Blood Pressure to Sustained Muscle Contraction

    Time frame: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)

    This assessment evaluates the autonomic nervous system's response to sustained muscle contraction by measuring blood pressure. Blood pressure are measured while the participant is lying comfortably for 20 minutes in a relaxed state. Then, the participant holds a hand dynamometer at 30% of their maximum grip strength for 5 minutes, during which blood pressure are recorded. Afterward, the participant rests for 10 minutes in a relaxed position, and the measurements are taken again.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Evaluation of the Efficacy and Safety of High-Definition Transcranial Direct Current Stimulation for Pain Reduction in Post-Stroke Pain Patients: Investigator-Initiated, Single-Center, Randomized, Crossover, Single-Blind Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 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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