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

N/AActive Not RecruitingNCT06740591

Pusan National University Yangsan Hospital30 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Pain CPSP TDCS

Interventions

HD-tDCSDEVICE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, South Korea

Outcomes

Primary Outcomes

Change of pain score in Brief Pain Inventory(BPI)

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).

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)

Secondary Outcomes

Change of pain score in Neuropathic Pain Scale(NPS)

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.

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

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.

Data from ClinicalTrials.gov

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