Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Pain Perception, Pain Acute

Intervention / Treatment
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* Behavioral: Hypnotic analgesia
* Device: a-tDCS
* Other: Hypnotic analgesia + a-tDCS
* Device: s-tDCS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Hypnotic analgesia + a-tDCS Hypnotic analgesia + s-tDCS Hypnotic analgesia a-tDCS
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotic analgesia<br>Intervention: - Subjects will receive hypnotic analgesia | Behavioral: Hypnotic analgesia<br>* Subjects will receive hypnotic analgesia during 20 minutes<br>|
| Experimental: a-tDCS<br>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<br>* Subjects will receive hypnotic analgesia during 20 minutes<br>Device: s-tDCS<br>* Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes<br>|
| Sham Comparator: s-tDCS<br>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<br>* Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes<br>Other: Hypnotic analgesia + a-tDCS<br>* Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes<br>|
| Experimental: Hypnotic analgesia + a-tDCS<br>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<br>* Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain perception, tDCS, Hypnosis, cortical activity