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

NCT ID: NCT04432363

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2020-07-25

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Processing in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Three groups cross over study with two intervention groups and one sham group.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M1 stimulation

A 20 minutes 1mA direct current stimulation over left M1.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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).

M1+DLPFC stimulation

A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josue Fernandez Carnero, PhD

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

Related Links

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http://www.urjc.es

Rey Juan Carlos University

Other Identifiers

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30012020204820

Identifier Type: -

Identifier Source: org_study_id