Effects of Transcranial Direct Current Stimulation on Pain Perception

NCT ID: NCT01860950

Last Updated: 2018-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

anodal tDCS

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

cathodal tDCS

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

cathodal tDCS

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

anodal tDCS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Transcranial Direct Current Stimulation Phoresor-II Auto Transcranial Direct Current Stimulation Phoresor-II Auto Transcranial Direct Current Stimulation Phoresor-II Auto

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Borckardt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00019694

Identifier Type: -

Identifier Source: org_study_id

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