Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers

Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.

The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.

Study Overview

• Status: Completed
• Conditions: Pain Processing in Healthy Volunteers
• Intervention / Treatment: Device: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Universidad Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 40 years
• Comprehension of the study tasks

Exclusion Criteria:

• Presence of pain in the previous 6 months
• Altered sensitivity in the tested regions
• Intolerance to electrotherapy
• Presence of pacemakers or any other implanted device
• Ulcers or scars in the skin at the location of the electrodes
• Treatment with direct current stimulation within one week
• Pregnancy
• Frequent headaches
• Epilepsy
• History of neuromuscular disease
• Previous clinical history of cervical surgery
• Injuries or surgery affecting the upper limb
• diabetes mellitus
• Cardiovascular diseases
• Oncological diseases
• Consumption of analgesic drugs 7 days before the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: M1 stimulation; A 20 minutes 1mA direct current stimulation over left M1.	Device: Transcranial direct current stimulation; Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
Active Comparator: M1+DLPFC stimulation; A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.	Device: Transcranial direct current stimulation; Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
Sham Comparator: Sham stimulation; A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp.	Device: Transcranial direct current stimulation; Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditioned Pain Modulation	Pain pressure threshold change after a painful ischemic stimulus	Pre-intervention and immediately after treatment
Pain pressure algometer temporal summation	Change in pain perceived between the first and tenth painful pressure stimulus	Pre-intervention and immediately after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain pressure threshold	Measurement of pressure applied until the perception of pain	Pre-intervention and immediately after treatment
Pain pressure tolerance	Measurement of maximal painful pressure tolerate using a pressure algometer	Pre-intervention and immediately after treatment
Neural mechanosensitivity	Measurement of range of motion achieved until the perception of tension	Pre-intervention and immediately after treatment
Cold hyperalgesia with a cold pack	Pain rated in a visual analogue scale after 10 seconds of a cold stimulus	Pre-intervention and immediately after treatment
Isometric grip strength	Maximal pressure achieved in a isometric gripping task	Pre-intervention and immediately after treatment

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Investigators: Study Director: Josue Fernandez Carnero, PhD, Rey Juan Carlos University

Publications and helpful links

Helpful Links

• Rey Juan Carlos University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Actual): July 25, 2020
• Study Completion (Actual): July 25, 2020

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 30012020204820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No