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

Not Applicable

Active, not recruiting

• Conditions: Stroke; Pain; CPSP; TDCS

• Registration Number: NCT06740591
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-24
• Primary Completion: 2024-04-24
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change of pain score in Brief Pain Inventory(BPI)	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 Outcome Measures

Name	Time	Method
Change of pain score in Neuropathic Pain Scale(NPS)	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.
Change of depression score in Beck Depression Inventory-II(BDI-II)	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.
Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)	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.
Change in Blood Pressure to Sustained Muscle Contraction	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.

Trial Locations

Locations (1)

Pusan national university Yangsan Hospital; 🇰🇷 Gyeongsang, Yangsan, Korea, Republic of