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Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

Primary Purpose

Pain Perception, Pain Acute

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hypnotic analgesia
a-tDCS
Hypnotic analgesia + a-tDCS
s-tDCS
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain Perception focused on measuring pain perception, tDCS, Hypnosis, cortical activity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Hospital de Clinicas de Porto Alegre
  • Hospital de Clinicas e Porto Alegre (HCPA)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Experimental

Arm Label

Hypnotic analgesia

a-tDCS

s-tDCS

Hypnotic analgesia + a-tDCS

Arm Description

Intervention: - Subjects will receive hypnotic analgesia

Intervention: transcranial direct current stimulation - tDCS active tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current:2 milliamps time: 20 minutes

Sham comparator: transcranial direct current stimulation - tDCS sham tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current: 0 milliamps time: 20 minutes

Intervention: hypnotic analgesia active tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current:2 milliamps time: 20 minutes

Outcomes

Primary Outcome Measures

Change in Alpha waves
Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test
Change in Theta waves
Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test

Secondary Outcome Measures

Change in beta waves
Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Change in gamma waves
Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test
Change in delta waves
Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 21, 2017
Last Updated
November 22, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03744897
Brief Title
Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain
Official Title
Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Perception, Pain Acute
Keywords
pain perception, tDCS, Hypnosis, cortical activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Hypnotic analgesia + a-tDCS Hypnotic analgesia + s-tDCS Hypnotic analgesia a-tDCS
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects are blinded to wether group they will be allocated Assessor will be blinded and the investigator not involved in subjects assessment will perform the hypnosis.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnotic analgesia
Arm Type
Experimental
Arm Description
Intervention: - Subjects will receive hypnotic analgesia
Arm Title
a-tDCS
Arm Type
Experimental
Arm Description
Intervention: transcranial direct current stimulation - tDCS active tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current:2 milliamps time: 20 minutes
Arm Title
s-tDCS
Arm Type
Sham Comparator
Arm Description
Sham comparator: transcranial direct current stimulation - tDCS sham tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current: 0 milliamps time: 20 minutes
Arm Title
Hypnotic analgesia + a-tDCS
Arm Type
Experimental
Arm Description
Intervention: hypnotic analgesia active tDCS stimulation montage: bilateral DLPFC anodal/left and cathodal/right current:2 milliamps time: 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
Hypnotic analgesia
Intervention Description
Subjects will receive hypnotic analgesia during 20 minutes
Intervention Type
Device
Intervention Name(s)
a-tDCS
Intervention Description
Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Intervention Type
Other
Intervention Name(s)
Hypnotic analgesia + a-tDCS
Intervention Description
Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Intervention Type
Device
Intervention Name(s)
s-tDCS
Intervention Description
Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
Primary Outcome Measure Information:
Title
Change in Alpha waves
Description
Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test
Time Frame
60 minutes
Title
Change in Theta waves
Description
Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Change in beta waves
Description
Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Time Frame
60 minutes
Title
Change in gamma waves
Description
Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test
Time Frame
60 minutes
Title
Change in delta waves
Description
Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Time Frame
60 minutes
Title
Change in Heat thermal threshold
Description
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.
Time Frame
60 minutes
Title
Change in Heat pain threshold
Description
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.
Time Frame
60 minutes
Title
Change in Heat pain tolerance
Description
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.
Time Frame
60 minutes
Title
Change in Numeric pain scale during CPM task
Description
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.
Time Frame
60 minutes
Title
Change in Cold Pressor Test 0 to 1 degree Celsius - time
Description
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.
Time Frame
60 minutes
Title
Change in Cold Pressor Test 10 degree Celsius - time
Description
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.
Time Frame
60 minutes
Title
Change in Cold Pressor Test 10 degree Celsius - pain
Description
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.
Time Frame
60 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, MD. PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.450-120
Country
Brazil
Facility Name
Hospital de Clinicas e Porto Alegre (HCPA)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25287554
Citation
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.
Results Reference
result
PubMed Identifier
24535464
Citation
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.
Results Reference
result
PubMed Identifier
15571771
Citation
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.
Results Reference
result
PubMed Identifier
30022928
Citation
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.
Results Reference
result
PubMed Identifier
16148743
Citation
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.
Results Reference
result
PubMed Identifier
32982393
Citation
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.
Results Reference
derived
PubMed Identifier
31297046
Citation
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.
Results Reference
derived

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Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

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