Transcranial Direct Current StimulationNCT03898245
Effectiveness of Transcranial Direct Current Stimulation for TKR
A study testing apply tDCS in people with Transcranial Direct Current Stimulation and Post Operative Pain, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Transcranial Direct Current Stimulation, Post Operative Pain
- What is being tested?
- apply tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2019to 10 May 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have scheduled elective spine surgery.
Who cannot join
- Who has Cognitive dysfunction before surgery.
- Who already has delirium before surgery.
- Who has pain disorder ( like CRPS)
- Who cannot reveal the one's pain.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery
Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states.
The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,
- Being tested
- apply tDCS, Sham tDCS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apply tDCSDevice
Intensity 2mA, 20minues, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC
Sham tDCSDevice
Intensity 0mA, 40 seconds, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | intervention : Intensity 2mA, 30minues, 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS Receives: Device: apply tDCS |
| sham tDCS | Sham comparator | Intensity 2mA, 8 seconds (but looks same as an intervention 30mins), 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS (sham mode) Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
the decrease of pain scale in postop state with Visual Analog Scale.
Measured: 1hour, 6hours, 24 hours, 48 hours
Secondary outcomes (2)
Incidence of Delirium
Incidence of Delirium
Measured: postop day 1,3,6
Consumption of PCA
The consumption of opioid.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion10 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, MD,phD, Principal investigator, Seoul Metropolitan Government Seoup National University Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898245
- Sponsor's protocol ID
- 2018/00/0000.0
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lefaucheur JP. A comprehensive database of published tDCS clinical trials (2005-2016). Neurophysiol Clin. 2016 Dec;46(6):319-398. doi: 10.1016/j.neucli.2016.10.002. Epub 2016 Nov 17.
PubMed 27865707Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, George MS. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011 Jun;73(6):1158-64. doi: 10.1016/j.gie.2011.01.050. Epub 2011 Apr 5.
PubMed 21470608Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.
PubMed 23370085
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT03898245
- Acronym / sponsor ID
- 2018/00/0000.0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 10 May 2020 (estimated)
- First posted
- 1 Apr 2019 (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.
Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states.
The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: apply tDCSintervention : Intensity 2mA, 30minues, 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS |
| sham tDCS | Sham comparator | Device: Sham tDCSIntensity 2mA, 8 seconds (but looks same as an intervention 30mins), 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS (sham mode) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who have scheduled elective spine surgery.
Key exclusion criteria (4 listed)
- Who has Cognitive dysfunction before surgery.
- Who already has delirium before surgery.
- Who has pain disorder ( like CRPS)
- Who cannot reveal the one's pain.
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 |
|---|---|---|
| apply tDCSIntensity 2mA, 20minues, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC | Device | active tDCS |
| Sham tDCSIntensity 0mA, 40 seconds, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC | Device | sham tDCS |
Primary outcome
VAS score
Time frame: 1hour, 6hours, 24 hours, 48 hours
the decrease of pain scale in postop state with Visual Analog Scale.
2 secondary outcomes
Incidence of Delirium
Time frame: postop day 1,3,6
Consumption of PCA
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 27865707Lefaucheur JP. A comprehensive database of published tDCS clinical trials (2005-2016). Neurophysiol Clin. 2016 Dec;46(6):319-398. doi: 10.1016/j.neucli.2016.10.002. Epub 2016 Nov 17.
- Background: PubMed 21470608Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, George MS. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011 Jun;73(6):1158-64. doi: 10.1016/j.gie.2011.01.050. Epub 2011 Apr 5.
- Background: PubMed 23370085Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.
- 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.
Jin-Young Hwang, MD,phD principal investigator
Seoul Metropolitan Government Seoup National University Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apply tDCS in people with Transcranial Direct Current Stimulation and Post Operative Pain, run by SMG-SNU Boramae Medical Center 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Hwang, MD, phD (+82-10-2746-4750, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 1hour, 6hours, 24 hours, 48 hours). 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 NCT03898245, which also lists 3 linked publications.
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 1 Apr 2019; AzTrials last refreshed its copy on 2 Nov 2026.