Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females

Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).

Study Overview

• Status: Completed
• Conditions: Pain Acute; Pain Perception
• Intervention / Treatment: Behavioral: Hypnotic analgesia; Device: s-tDCS; Device: a-tDCS; Other: Hypnotic analgesia + a-tDCS

Detailed Description

Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of <0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Hospital de Clinicas e Porto Alegre (HCPA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy
• Female
• 11 years of schooling
• 12 cut-off at Waterloo-Stanford Group C (WSGC)

Exclusion Criteria:

• hearing loss subjects
• formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotic analgesia; Intervention: - Subjects will receive hypnotic analgesia	Behavioral: Hypnotic analgesia; Subjects will receive hypnotic analgesia during 20 minutes
Experimental: a-tDCS; Intervention: transcranial direct current stimulation - tDCS; active tDCS stimulation; montage: bilateral DLPFC anodal/left and cathodal/right; current:2 milliamps; time: 20 minutes	Behavioral: Hypnotic analgesia; Subjects will receive hypnotic analgesia during 20 minutes; Device: s-tDCS; Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
Sham Comparator: s-tDCS; Sham comparator: transcranial direct current stimulation - tDCS; sham tDCS stimulation; montage: bilateral DLPFC anodal/left and cathodal/right; current: 0 milliamps; time: 20 minutes	Device: a-tDCS; Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes; Other: Hypnotic analgesia + a-tDCS; Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Experimental: Hypnotic analgesia + a-tDCS; Intervention: hypnotic analgesia; active tDCS stimulation; montage: bilateral DLPFC anodal/left and cathodal/right; current:2 milliamps; time: 20 minutes	Other: Hypnotic analgesia + a-tDCS; Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alpha waves	Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Change in Theta waves	Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in beta waves	Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Change in gamma waves	Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Change in delta waves	Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Change in Heat thermal threshold	The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat thermal threshold (HTT) is the averaged temperature for 3 stimuli where participant indicates the first heat sensation.	60 minutes
Change in Heat pain threshold	The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain threshold (HPT) is the averaged temperature for 3 stimuli where participant indicates the first heat pain sensation.	60 minutes
Change in Heat pain tolerance	The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain tolerance (HPTo) is the temperature for the stimulus where participant indicates the maximum pain tolerance.	60 minutes
Change in Numeric pain scale during CPM task	The measure will be assessed by the conditioned pain modulation (CPM) task in which an ice cold water (0 a 1 degrees Celsius) is the conditioning stimulus presented to the left hand and a moderate heat pain stimulus from the QST to the contralateral hand. The measure consists of the response using a numeric pain scale (0 - 10) for the heat pain stimulus during the CPM task.	60 minutes
Change in Cold Pressor Test 0 to 1 degree Celsius - time	Participant puts his right hand in an ice cold water (0 a 1 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerance.	60 minutes
Change in Cold Pressor Test 10 degree Celsius - time	Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerate.	60 minutes
Change in Cold Pressor Test 10 degree Celsius - pain	Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the response to a numeric pain scale (0 to 10) to the pain sensation when the participant withdraw his hand from the water.	60 minutes

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Wolnei Caumo, MD. PhD, Federal University of Rio Grande do Sul

Publications and helpful links

General Publications

• Jensen MP, Sherlin LH, Fregni F, Gianas A, Howe JD, Hakimian S. Baseline brain activity predicts response to neuromodulatory pain treatment. Pain Med. 2014 Dec;15(12):2055-63. doi: 10.1111/pme.12546. Epub 2014 Oct 7.
• Jensen MP, Day MA, Miro J. Neuromodulatory treatments for chronic pain: efficacy and mechanisms. Nat Rev Neurol. 2014 Mar;10(3):167-78. doi: 10.1038/nrneurol.2014.12. Epub 2014 Feb 18.
• Vanegas H, Schaible HG. Descending control of persistent pain: inhibitory or facilitatory? Brain Res Brain Res Rev. 2004 Nov;46(3):295-309. doi: 10.1016/j.brainresrev.2004.07.004.
• Foerster AS, Rezaee Z, Paulus W, Nitsche MA, Dutta A. Effects of Cathode Location and the Size of Anode on Anodal Transcranial Direct Current Stimulation Over the Leg Motor Area in Healthy Humans. Front Neurosci. 2018 Jul 4;12:443. doi: 10.3389/fnins.2018.00443. eCollection 2018.
• Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.
• Beltran Serrano G, Pooch Rodrigues L, Schein B, Zortea M, Torres ILS, Fregni F, Caumo W. The Hypnotic Analgesia Suggestion Mitigated the Effect of the Transcranial Direct Current Stimulation on the Descending Pain Modulatory System: A Proof of Concept Study. J Pain Res. 2020 Sep 16;13:2297-2311. doi: 10.2147/JPR.S253747. eCollection 2020.
• Beltran Serrano G, Rodrigues LP, Schein B, Souza A, Torres ILS, da Conceicao Antunes L, Fregni F, Caumo W. Comparison of Hypnotic Suggestion and Transcranial Direct-Current Stimulation Effects on Pain Perception and the Descending Pain Modulating System: A Crossover Randomized Clinical Trial. Front Neurosci. 2019 Jun 26;13:662. doi: 10.3389/fnins.2019.00662. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: tDCS; Hypnosis; pain perception; cortical activity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 16-0635

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