Transcranial Versus Suboccipital Direct Current Stimulation

March 13, 2020 updated by: University of Castilla-La Mancha

Effectiveness of Transcranial and Suboccipital Direct Current Stimulation on Endogenous Pain Modulation System in Healthy Volunteers.

Randomized controlled trial, in parallel with cross-control design. Two groups of healthy subjects will be randomly selected to transcranial stimulation group or suboccipital stimulation group. Each group receive in a randomized order a real direct current session and a sham session. The study is based on the hypothesis that the application of direct current sitmulation applied at the suboccipital level produce higher modifications on endogenous pain modulation system than transcranial stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The development of the project will be based on the Declarations of the World Medical Association of Helsinki. Every subject will be informed about the nature of the study, willingness to participate, the proposed objectives, as well as possible adverse effects that may occur in its implementation. Every subject will be asked to give their signed consent to participate in the study. The study will be suspended at any time, if the patient wishes.

Healthy volunteers will be recruited from the city of Toledo, between the ages of 18 and 40. The detection and selection of the sample will be carried out between the students of the University of Castilla-La Mancha and personnel of the Hospital Nacional de Parapléjicos who meet the inclusion criteria and give their consent voluntarily to participate in the study.

The calculation of the sample size will be carried out using the G * Power software program (version 3.1), for clinical studies with two intervention groups. Conditioned pain modulation will be chosen as the primary outcome variable. Assuming an α level of 0.05 and a statistical power of 85%, with a moderate effect size for the ANOVA test (0.25).

The experiment will be carried out in the clinical laboratory of the Sensory-Motor Function Research Group of the Hospital Nacional de Parapléjicos. Under attenuated sound conditions, and at a stable temperature in the range of (22 °C-26 °C).

In the first session of the study, a small interview will be carried out to determine if there is any exclusion criterion. The initial measurements will consist of sociodemographic variables and psychological variables, which will then be used to categorize groups and analyze covariates. A parallel randomized controlled trial with cross-control design is proposed. Two groups of healthy subjects will be randomly selected to transcranial direct current stimulation (DCS) group or suboccipital DCS group. Each group receive in a randomized order and with a double blind design a real direct current session and a sham session. An assessment is made before and after each intervention.

Subjects will remain in a sitting position, with their backs resting in a relaxed position. In all interventions a direct current stimulator (DC-stimulator, Neuroconn) will be used.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45071
        • Hospital Nacional de Parapléjicos de Toledo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 40 years.
  • Healthy volunteers (without neurological injury and no history of pain in the last 6 months).
  • Ability to perform all clinical test and understand the process of the study, as well as obtaining informed consent.
  • Tolerance to the application of electrotherapy.

Exclusion Criteria:

  • Previous history of surgical intervention at the cervical level.
  • Have been treated with an electric current similar to that applied prior to the intervention.
  • Sensitivity altered in the area of application of the intervention.
  • No commitment to continuity.
  • History of neuromuscular disease.
  • Epilepsy.
  • Injuries, surgery or pain affecting the upper limb.
  • Material of osteosynthesis at the cervical level.
  • Diabetes.
  • History of cancer.
  • Cardiovascular disease.
  • Presence of pacemakers or any other implanted electrical device.
  • Take medication during the study and in the 7 days prior to the study.
  • Consumption of narcotic substances during the study and in the 7 days prior to the study.
  • Presence of tattoos or any other external agent introduced in the treatment and assessment area (hand).
  • Pregnancy.
  • Presence of severe and frequent headaches.
  • Ulcers or scars in the skin at the location of the electrodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial Stimulation
Transcranial stimulation on the primary motor cortex (M1) with anode located on the point C3 (10/20 EEG system), and the cathode on contralateral supraorbital zone.
Device: Direct Current Stimulation
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
Device: Sham DCS
20 minutes of sham stimulation. Subjects will be stimulated during the first 30 seconds. After that, a ramp down of 10 seconds and then the stimulator is turned-off.
Active Comparator: Suboccipital Stimulation
Suboccipital stimulation with anode located at the upper cervical level and cathode was placed on the lateral part of right shoulder.
Device: Direct Current Stimulation
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
Device: Sham DCS
20 minutes of sham stimulation. Subjects will be stimulated during the first 30 seconds. After that, a ramp down of 10 seconds and then the stimulator is turned-off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditioned Pain Modulation
Time Frame: Baseline at 0 min
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
Baseline at 0 min
Change from baseline Conditioned Pain Modulation
Time Frame: At 30 min
For this protocol the test stimulus (TS) and the conditioning stimulus (CS) will be applied sequentially (first CS, followed by TS), heterotopic, and contralateral. The CS temperature will be 12 °C on the cold pressor test to induce a perception of pain. The subjects will have to submerge the non-dominant hand in the cold water bath for 30s, and evaluate the CS-induced pain intensity at 10, 20, and 30s (t1, t2 and t3 respectively). After assessing CS-induced pain intensity at the 30s of immersion participants will withdraw their hand from the water bath, and will have to fix their attention to the dominant hand where TS was immediately applied. The TS-induced pain assessment at 10, 20, and 30s (t1, t2 and t3).
At 30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Temporal Summation
Time Frame: At 5 min
For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10).
At 5 min
Change from baseline Temporal Summation
Time Frame: At 35 min
For the evaluation of the habituation and temporal summation of pain, heat stimuli of a "p-3" intensity without conditioning stimulus (CS) will be applied. The tonic heat stimulus will be applied on the surface of the tenar eminence of the dominant hand by 8 consecutive stimuli separated from each other by 1.5 seconds, evaluating the pain perceived during the first and the eighth stimulus, and at 15 seconds after the stimulation. The temperature will be determined individually, in order to reflect the general level of discomfort that the stimulus could produce according to the visual analog scale (0-10).
At 35 min
Baseline Pressure Pain Threshold
Time Frame: at 10 min
To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure.
at 10 min
Change from baseline Pressure Pain Threshold
Time Frame: at 40 min
To record the mechanical pain threshold, a point will be marked on the Tibialis Anterior muscle and on the dorsal surface of the right hand, specifically on the second metacarpal lateral border, approximately 3 cm proximal to the interdigital fold. This zone is especially sensitive to pressure. For registration, the digital algometer with 0.1 N increment scale (Wagner Instruments brand, model FDIX), with a circular applicator of 1 cm in diameter will be used. Once the applicator is placed perpendicular to the skin, the pressure will increase at a rate of approximately 5 N / s. Three measures will be taken with an interval between measures of 10 seconds, the average of the three measurements will be taken as threshold of pain to the pressure.
at 40 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Questionnaire (STAI-ES)
Time Frame: At 0 min
We will use the adapted version to the Spanish of the State Scale (STAI-ES) of the "State-Trait Anxiety Questionnaire" (STAI). The STAI is a well-known scale of self-report, comprising two self-assessment subscales that measure two concepts of anxiety: state (S) and trait (T). It is composed of 40 items with 4 possible answers each (score 0 to 3). The total scores for each of the subscales range from 0 to 60 points. Specifically STAI-ES evaluates the anxiety-state in a great variety of situations.
At 0 min
Beck Depression Inventory (BDI).
Time Frame: At 0 min
Most commonly used questionnaire at the global and national levels to assess depression. We will use the adaptation to the Spanish of the Beck II depression inventory. It consists of 21 items to measure the affective, cognitive situation and the signs and symptoms of depression during the last two weeks. High scores indicate high levels of depressive symptoms. This inventory has demonstrated excellent psychometric properties
At 0 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Universidad Rey Juan Carlos
Hospital Nacional de Parapléjicos de Toledo

Investigators

  • Study Director: Julian Scott Taylor, Physiology, Hospital Nacional de Parapléjicos de Toledo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

October 4, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GuillermoGB
  • 0220493 (Registry Identifier: Guillermo García Barajas)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shown if requested

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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