Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

Pain Perception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744897
• Other study ID #: 16-0635
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain Acute
• Pain Perception

Intervention

Behavioral:
• Hypnotic analgesia
Subjects will receive hypnotic analgesia during 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

Device:
• s-tDCS
Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clinicas e Porto Alegre (HCPA)	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Foerster ÁS, 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 — View 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):1 — View Citation

Jensen MP, Day MA, Miró 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. Review. — View 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. — View Citation

Vanegas H, Schaible HG. Descending control of persistent pain: inhibitory or facilitatory? Brain Res Brain Res Rev. 2004 Nov;46(3):295-309. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alpha waves	Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Primary	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	Change in beta waves	Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Secondary	Change in gamma waves	Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Secondary	Change in delta waves	Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test	60 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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