Effects of Transcranial Direct Current Stimulation on Pain Perception (tDCS-CBT)

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).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: anodal tDCS; Device: cathodal tDCS; Device: sham tDCS

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants That Correctly Guessed Condition Assignment	Participants guessed whether they received real tDCS or Sham tDCS. The base-rate for correctly guessing real versus sham was 50%.	2 hours

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Jeffrey Borckardt, Ph.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Adults; Pain Perception
• Other Study ID Numbers: Pro00019694

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No