Transcranial Versus Suboccipital Direct Current Stimulation

NCT04117256 | Completed DMC

• 2 other identifiers: GuillermoGB0220493
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Transcranial Direct Current Stimulation

Keywords

Direct Current Stimulation; Conditioned Pain Modulation; Endogenous Pain Modulation; Temporal Summation; Pressure Pain Threshold; Pain

Outcome Measures

Primary Outcomes (2)

• Conditioned Pain Modulation

  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

  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 Outcomes (4)

• Baseline Temporal Summation

  At 5 min

• Change from baseline Temporal Summation

  At 35 min

• Baseline Pressure Pain Threshold

  at 10 min

• Change from baseline Pressure Pain Threshold

  at 40 min

Other Outcomes (2)

• State-Trait Anxiety Questionnaire (STAI-ES)

  At 0 min

• Beck Depression Inventory (BDI).

  At 0 min

Study Arms (2)

Transcranial Stimulation

ACTIVE COMPARATOR

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; Device: Sham DCS

Suboccipital Stimulation

ACTIVE COMPARATOR

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; Device: Sham DCS

Interventions

Direct Current Stimulation DEVICE

20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm

Suboccipital Stimulation; Transcranial Stimulation

Sham DCS DEVICE

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; Transcranial Stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Universidad Rey Juan Carlos: collaborator
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Study Sites (1)

Hospital Nacional de Parapléjicos de Toledo

Toledo, 45071, Spain

Location

Related Publications (13)

• 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.

  PMID: 25919472 BACKGROUND

• 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.

  PMID: 20824873 BACKGROUND

• 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.

  PMID: 21320389 BACKGROUND

• 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.

  PMID: 22037126 BACKGROUND

• 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.

  PMID: 25599447 BACKGROUND

• 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.

  PMID: 25789433 BACKGROUND

• 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.

  PMID: 24558475 BACKGROUND

• 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.

  PMID: 19359095 BACKGROUND

• 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.

  PMID: 9474108 BACKGROUND

• 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.

  BACKGROUND

• Spielberger CD. Manual for the State-Trait Anxiety Inventory (STAI Form Y). Consult Psychol Palo Alto. 1983;4-6.

  BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

• 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.

  PMID: 16564618 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Julian Scott Taylor, Physiology

  Hospital Nacional de Parapléjicos de Toledo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the assessor: all the assessments will be made by a different researcher who apply all the interventions. Assessor will not have vision of the place where the electrodes are located neither the parameters used. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paralled randomized controlled trial with cross-control design. Two groups of subjects will be randomly selected, a Transcranial stimulation group and a suboccipital stimulation group. Each group will perform two intervention sessions in a randomized order, a session with direct current stimulation and a sham stimulation session.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: October 10, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 30, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)