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Trial record 1 of 1 for:    NCT01860950
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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
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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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).

Condition or disease Intervention/treatment Phase
Pain Device: anodal tDCS Device: cathodal tDCS Device: sham tDCS Not Applicable

Detailed Description:
Healthy subjects underwent thermal pain tolerance testing pre- and post intervention. The intervention includes either anodal, cathodal, or sham tDCS for 20 minutes during a pain cognitive intervention [either brief cognitive intervention (BCI) or general pain education]. The tDCS brand was the Phoresor-II Auto (Model PM850, Iomed, Salt Lake City Utah, USA) and the current was set to 2.0mA. Electrodes were 4x4 cm sponge electrodes soaked in sterile saline. For anodal and cathodal tDCS, One electrode was placed over the left DLPFC (F3 from the EEG 10-20 system) located via the Beam F3 measurement system and the other electrode was attached to the right shoulder. For sham tDCS, 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.

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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.
 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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto
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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto
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.
 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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto
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.
 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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto
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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto
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:
  • Transcranial Direct Current Stimulation
  • Phoresor-II Auto


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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%.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Jeffrey Borckardt, Ph.D. Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] July 18, 2016
Informed Consent Form  [PDF] August 2, 2016

More Information
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01860950     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
Healthy Adults
Pain Perception