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

NCT06740591 | Active Not Recruiting

• 1 other identifier: 23-2023-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Stroke; Pain; CPSP; TDCS

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Experimental : HD-tDCS

EXPERIMENTAL

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

Device: HD-tDCS

Sham HD-tDCS

SHAM COMPARATOR

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

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

Interventions

HD-tDCS DEVICE

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

Experimental : HD-tDCS

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.

Sham HD-tDCS

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[basal ganglia (BG) or thalamus\].
• Cognitive ability sufficient to understand and follow the instructions of the researcher.
• Voluntary consent to participate in the clinical trial and signed informed consent.

You may not qualify if:

• 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.
• Deemed unsuitable for participation in the study by the principal investigator.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Young-Il Shin, Dr.

  Pusan National University Yangsan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: November 24, 2023
• Primary Completion: April 24, 2024
• Study Completion: July 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)