Effects of Transcranial Direct Current Stimulation on Pain Perception (tDCS-CBT)
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ClinicalTrials.gov Identifier: NCT01860950 |
Recruitment Status :
Completed
First Posted : May 23, 2013
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
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Condition or disease | Intervention/treatment | Phase |
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Pain | Device: anodal tDCS Device: cathodal tDCS Device: sham tDCS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Effects of Transcranial Direct Current Stimulation on Pain Perception |
Actual Study Start Date : | October 2012 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |
Arm | Intervention/treatment |
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Active Comparator: anodal tDCS plus BCI
Participants 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.
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Device: anodal tDCS
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
Other Names:
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Active Comparator: anodal tDCS plus pain-education
Participants 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. |
Device: anodal tDCS
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
Other Names:
|
Experimental: cathodal tDCS plus BCI
Participants 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.
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Device: cathodal tDCS
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.
Other Names:
|
Experimental: cathodal tDCS plus pain-education
Participants 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.
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Device: cathodal tDCS
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.
Other Names:
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Sham Comparator: sham tDCS plus BCI
Participants 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.
|
Device: sham tDCS
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
Other Names:
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Sham Comparator: sham tDCS plus pain-education
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. Pain Education information included Pain Physiology, info on the Gate Theory of Pain, and Central Pain Processing.
|
Device: sham tDCS
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
Other Names:
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- Pre-Intervention Pain Tolerance [ Time Frame: Duration of the study visit, approximately 2 hours ]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.
- Post-Intervention Pain Tolerance [ Time Frame: Duration of the study visit, approximately 2 hours ]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.
- Percentage of Participants That Correctly Guessed Condition Assignment [ Time Frame: 2 hours ]Participants guessed whether they received real tDCS or Sham tDCS. The base-rate for correctly guessing real versus sham was 50%.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion Criteria:
- 100 Health Individuals recruited from Charleston ,SC
Exclusion Criteria:
- Can not be pregnant
- No history of Depression, chronic pain, Seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860950
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Jeffrey Borckardt, Ph.D. | Medical University of South Carolina |
Documents provided by Medical University of South Carolina:
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT01860950 |
Other Study ID Numbers: |
Pro00019694 |
First Posted: | May 23, 2013 Key Record Dates |
Results First Posted: | December 4, 2018 |
Last Update Posted: | December 4, 2018 |
Last Verified: | December 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Healthy Adults Pain Perception |