Pain, ChronicNCT05612165

Effectiveness and Safety of tDCS for Pain

A study testing Transcranial Direct Current Stimulation(tDCS) in people with Pain, Chronic, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Pain, Chronic
What is being tested?: Transcranial Direct Current Stimulation(tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteSouth Korea
Study dates: 9 Jun 2022to 31 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

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 19 to 90 years old
Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis
A person whose stroke lesions are cortex or subcortex
A person who satisfies 'Mandatory criteria'
Those with cognitive ability to understand and follow the researcher's instructions
Those who voluntarily agree to participate in this clinical trial and signed the agreement

Who cannot join

Those who have a fracture or have undergone orthopedic surgery
In case of accompanying serious neurological diseases
In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
Those with complex part pain syndrome by Budapest Criteria
If there is a cause of other pain in the relevant area, such as peripheral nerve damage
Persons included in the exclusion of transcranial direct current stimulation
If the researcher is judged to be judged that the participation in this study is not appropriate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610

Other trials in South Korea

About this study

Official title: Effectiveness and Safety of Transcranial Direct Current Stimulation for Pain Changes in Patients With Central Post-Stroke Pain

The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain.

Conditions: Pain, Chronic
Being tested: Transcranial Direct Current Stimulation(tDCS), Sham Transcranial Direct Current Stimulation(sham tDCS)
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current Stimulation(tDCS)Device
The tDCS intervention was conducted for 20 minutes(2000μA) each time, 5 times a week for 2 weeks, a total of 10 times.
Sham Transcranial Direct Current Stimulation(sham tDCS)Device
The sham tDCS intervention was conducted for 20 minutes(0μA) each time, 5 times a week for 2 weeks, a total of 10 times.

Study groups in NCT05612165
Study group	Role	What they receive
tDCS group	Experimental	Not described Receives: Device: Transcranial Direct Current Stimulation(tDCS)
Control group	Sham comparator	Not described Receives: Device: Sham Transcranial Direct Current Stimulation(sham 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)
Brief Pain Inventory(BPI) is used for measurement. The Brief Pain Inventory (BPI) is a tool used to assess pain severity and its impact on daily functions. The BPI typically uses an 11-point numeric rating scale (NRS) for its pain severity and pain interference items. Each item is rated from 0 to 10.
Pain Severity: 0 (no pain) to 10 (pain as bad as you can imagine). Pain Interference: 0 (does not interfere) to 10 (completely interferes).
Measured: Baseline, after 2 weeks(after the end of intervention)

Secondary outcomes (3)

Change of pain score in Neuropathic Pain Scale(NPS)
Neuropathic Pain Scale(NPS) is used for measurement. The Neuropathic Pain Scale (NPS) is a tool used to assess the various qualities and intensities of neuropathic pain. Each Item: 0 (no pain or absence of the described pain quality) to 10 (the most intense pain or presence of the described pain quality imaginable).
Measured: Baseline, after 2 weeks(after the end of intervention)
Change of depression score in Beck Depression Inventory-II(BDI-II)
Beck Depression Inventory-II(BDI-II) is used for measurement. The Beck Depression Inventory-II (BDI-II) is a widely used instrument for measuring the severity of depression. Minimum and Maximum Values: The BDI-II consists of 21 items, each rated on a 4-point scale ranging from 0 to 3. Total Score Range: 0 to 63. Each Item: 0 (symptom is absent) to 3 (severe level of the symptom).
Measured: Baseline, after 2 weeks(after the end of intervention)
Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)
The EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L) is used for measurement. The EuroQol Five-Dimensions-Three-Level Quality of Life Instrument (EQ-5D-3L) is a standardized instrument used to measure health-related quality of life. This utility score reflects the overall quality of life associated with each health state and typically ranges from -0.594 to 1 in the UK: A value closer to 1 indicates a better health state.
Measured: Baseline, after 2 weeks(after the end of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 202231 Jul 2024

First posted10 Nov 2022
Study start9 Jun 2022
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, ChronicStudies 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05612165
Sponsor's protocol ID: 03-2022-001
Status last verified: Aug 2024
First submitted: 3 Nov 2022
Last updated: 6 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Pain, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Transcranial Direct Current Stimulation for Pain Changes in Patients With Central Post-Stroke Pain
ClinicalTrials.gov ID: NCT05612165
Acronym / sponsor ID: 03-2022-001
Conditions: Pain, Chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Pusan National University Yangsan HospitalUniversity, hospital or other
Study start: 9 Jun 2022 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 10 Nov 2022 (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.

The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
tDCS group	Experimental	Device: Transcranial Direct Current Stimulation(tDCS)
Control group	Sham comparator	Device: Sham Transcranial Direct Current Stimulation(sham tDCS)

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 19 to 90 years old
Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis
A person whose stroke lesions are cortex or subcortex
A person who satisfies 'Mandatory criteria'
Those with cognitive ability to understand and follow the researcher's instructions

Key exclusion criteria (7 listed)

Those who have a fracture or have undergone orthopedic surgery
In case of accompanying serious neurological diseases
In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
Those with complex part pain syndrome by Budapest Criteria
If there is a cause of other pain in the relevant 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
Transcranial Direct Current Stimulation(tDCS)The tDCS intervention was conducted for 20 minutes(2000μA) each time, 5 times a week for 2 weeks, a total of 10 times.	Device	tDCS group
Sham Transcranial Direct Current Stimulation(sham tDCS)The sham tDCS intervention was conducted for 20 minutes(0μA) each time, 5 times a week for 2 weeks, a total of 10 times.	Device	Control group

Primary outcome

Change of pain score in Brief Pain Inventory(BPI)
Time frame: Baseline, after 2 weeks(after the end of intervention)
Brief Pain Inventory(BPI) is used for measurement. The Brief Pain Inventory (BPI) is a tool used to assess pain severity and its impact on daily functions. The BPI typically uses an 11-point numeric rating scale (NRS) for its pain severity and pain interference items. Each item is rated from 0 to 10. Pain Severity: 0 (no pain) to 10 (pain as bad as you can imagine). Pain Interference: 0 (does not interfere) to 10 (completely interferes).

3 secondary outcomes

Change of pain score in Neuropathic Pain Scale(NPS)
Time frame: Baseline, after 2 weeks(after the end of intervention)
Change of depression score in Beck Depression Inventory-II(BDI-II)
Time frame: Baseline, after 2 weeks(after the end of intervention)
Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)
Time frame: Baseline, after 2 weeks(after the end of intervention)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.

Related trials for Pain, Chronic

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation(tDCS) in people with Pain, Chronic, 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: finished, as of the sponsor's last update on 6 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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, after 2 weeks(after the end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612165.

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 6 Aug 2024.