Transcranial Versus Suboccipital Direct Current Stimulation
NCT ID: NCT04117256
Last Updated: 2020-03-16
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-10-10
2019-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Blinding of the subjects: Although subjects will be blinded to the hypothesis of the study, the transcranial and suboccipital location of the electrodes cannot be blinded. Direct current and sham stimulation will be blinded. For the sham condition subjects will feel the stimulation sensation for 30 seconds and then the stimulator will turn off. The same equipment, identical electrodes, and cables will be used. In addition, subjects will not have a view of the computer screen.
Blinding of the person who apply the intervention: Although transcranial and suboccipital conditions cannot be blinded. The direct current and sham stimulation will be apply by the blind-mode of the stimulator using locking codes.
Study Groups
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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.
Direct Current Stimulation
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
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.
Suboccipital Stimulation
Suboccipital stimulation with anode located at the upper cervical level and cathode was placed on the lateral part of right shoulder.
Direct Current Stimulation
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
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.
Interventions
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Direct Current Stimulation
20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Universidad Rey Juan Carlos
OTHER
Hospital Nacional de Parapléjicos de Toledo
OTHER
University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Julian Scott Taylor, Physiology
Role: STUDY_DIRECTOR
Hospital Nacional de Parapléjicos de Toledo
Locations
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Hospital Nacional de Parapléjicos de Toledo
Toledo, , Spain
Countries
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References
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Klein MM, Treister R, Raij T, Pascual-Leone A, Park L, Nurmikko T, Lenz F, Lefaucheur JP, Lang M, Hallett M, Fox M, Cudkowicz M, Costello A, Carr DB, Ayache SS, Oaklander AL. Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210.
O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD008208. doi: 10.1002/14651858.CD008208.pub2.
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
Albu S, Gomez-Soriano J, Avila-Martin G, Taylor J. Deficient conditioned pain modulation after spinal cord injury correlates with clinical spontaneous pain measures. Pain. 2015 Feb;156(2):260-272. doi: 10.1097/01.j.pain.0000460306.48701.f9.
Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015 Apr;156 Suppl 1:S24-S31. doi: 10.1097/01.j.pain.0000460343.46847.58.
Staud R, Weyl EE, Riley JL 3rd, Fillingim RB. Slow temporal summation of pain for assessment of central pain sensitivity and clinical pain of fibromyalgia patients. PLoS One. 2014 Feb 18;9(2):e89086. doi: 10.1371/journal.pone.0089086. eCollection 2014.
Pud D, Granovsky Y, Yarnitsky D. The methodology of experimentally induced diffuse noxious inhibitory control (DNIC)-like effect in humans. Pain. 2009 Jul;144(1-2):16-9. doi: 10.1016/j.pain.2009.02.015. Epub 2009 Apr 8. No abstract available.
Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. doi: 10.1093/ptj/78.2.160.
Sanz J, García-Vera MP, Espinosa R, Fortún M, Vázquez C. Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 3. Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud. 2005;16(2):121-42.
Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI Form Y). Consult Psychol Palo Alto. 1983;4-6.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
Other Identifiers
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0220493
Identifier Type: REGISTRY
Identifier Source: secondary_id
GuillermoGB
Identifier Type: -
Identifier Source: org_study_id
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