Effects of Transcranial Direct Current Stimulation on Pain Perception
tDCS-CBT
1 other identifier
interventional
79
1 country
1
Brief Summary
The purpose of this study is to determine whether a new medical technology can temporarily alter pain perception. The new technology is called Transcranial direct current stimulation (tDCS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Oct 2012
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
December 4, 2018
CompletedDecember 4, 2018
December 1, 2018
3.7 years
May 21, 2013
May 7, 2018
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pre-Intervention Pain Tolerance
Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.
Duration of the study visit, approximately 2 hours
Post-Intervention Pain Tolerance
Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.
Duration of the study visit, approximately 2 hours
Secondary Outcomes (1)
Percentage of Participants That Correctly Guessed Condition Assignment
2 hours
Study Arms (6)
anodal tDCS plus BCI
ACTIVE COMPARATORParticipants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder (Brand Phoresor-II Auto) . BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.
anodal tDCS plus pain-education
ACTIVE COMPARATORParticipants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
cathodal tDCS plus BCI
EXPERIMENTALParticipants underwent Brief Cognitive intervention (BCI) during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC. BCI entails listening to a 3-minute audio recording designed to mimic key components of cognitive behavioral therapy (CBT) for pain.
cathodal tDCS plus pain-education
EXPERIMENTALParticipants were provided pain education during a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode attached to the right shoulder and the cathode electrode was placed over the left DLPFC. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
sham tDCS plus BCI
SHAM COMPARATORParticipants underwent Brief Cognitive intervention (BCI) during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.
sham tDCS plus pain-education
SHAM COMPARATORParticipants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
Interventions
a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder
a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC.
Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session
Eligibility Criteria
You may qualify if:
- Health Individuals recruited from Charleston ,SC
You may not qualify if:
- Can not be pregnant
- No history of Depression, chronic pain, Seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jeffrey J. Borckardt
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Borckardt, Ph.D.
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
October 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 4, 2018
Results First Posted
December 4, 2018
Record last verified: 2018-12