NCT03898245

Brief 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. 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,

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 29, 2019

Last Update Submit

March 29, 2019

Conditions

Transcranial Direct Current StimulationPost Operative Pain

Outcome Measures

Primary Outcomes (1)

  • VAS score

    the decrease of pain scale in postop state with Visual Analog Scale.

    1hour, 6hours, 24 hours, 48 hours

Secondary Outcomes (2)

  • Incidence of Delirium

    postop day 1,3,6

  • Consumption of PCA

    24 hours

Study Arms (2)

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

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)

Device: Sham tDCS

Interventions

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

active tDCS
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

sham tDCS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have scheduled elective spine surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 27865707BACKGROUND

  • Borckardt 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.

    PMID: 21470608BACKGROUND

  • Borckardt 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.

    PMID: 23370085BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jin-Young Hwang, MD,phD

    Seoul Metropolitan Government Seoup National University Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Young Hwang, MD, phD

CONTACT

+82-10-2746-4750mistyblue15@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

May 1, 2019

Primary Completion

April 30, 2020

Study Completion

May 10, 2020

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)