StrokeNCT06740591
HD-tDCS for Pain Reduction in Post-Stroke Pain: a Randomized Crossover Trial
A study testing HD-tDCS in people with Stroke and Pain, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 19 to 90 years
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610
About this study
Official 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
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)
- Being tested
- HD-tDCS, Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS)
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : HD-tDCS | Experimental | The HD-tDCS stimulation was applied for 20 minutes, 5 times a week, over a total of 10 sessions. Receives: 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. Receives: Device: Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start24 Nov 2023
- Primary completion24 Apr 2024
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
- Investigators
- Young-Il Shin, Dr., Study director, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740591
- Sponsor's protocol ID
- 23-2023-001
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06740591
- Acronym / sponsor ID
- 23-2023-001
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : HD-tDCS | Experimental | Device: HD-tDCSThe HD-tDCS stimulation was applied for 20 minutes, 5 times a week, over a total of 10 sessions. |
| Sham HD-tDCS | Sham comparator | Device: Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS)The Sham HD-tDCS stimulation was applied for 20 minutes, 5 times a week, over a total of 10 sessions. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-tDCSThe HD-tDCS stimulation was applied for 20 minutes, 5 times a week, for a total of 10 sessions. | Device | Experimental : HD-tDCS |
| Sham High-Definition Transcranial Direct Current Stimulation(sham HD-tDCS)The Sham HD-tDCS stimulation was applied for 20 minutes, 5 times a week, for a total of 10 sessions. | Device | Sham HD-tDCS |
Primary outcome
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).
4 secondary outcomes
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Il Shin, Dr. study director
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS in people with Stroke and Pain, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.