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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01860950
Other study ID # Pro00019694
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date June 2016

Study information

Verified date December 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
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

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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