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Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Pain Acute
Pain Perception

Treatments

Behavioral: Hypnotic analgesia
Device: a-tDCS
Other: Hypnotic analgesia + a-tDCS
Device: s-tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03744897
16-0635

Details and patient eligibility

About

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).

Full 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.

Enrollment

48 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

48 participants in 4 patient groups

Hypnotic analgesia
Experimental group
Description:
Intervention: - Subjects will receive hypnotic analgesia
Treatment:
Behavioral: Hypnotic analgesia
a-tDCS
Experimental group
Description:
Intervention: transcranial direct current stimulation - tDCS * active tDCS stimulation * montage: bilateral DLPFC anodal/left and cathodal/right * current:2 milliamps * time: 20 minutes
Treatment:
Device: s-tDCS
Behavioral: Hypnotic analgesia
s-tDCS
Sham Comparator group
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
Treatment:
Device: a-tDCS
Other: Hypnotic analgesia + a-tDCS
Hypnotic analgesia + a-tDCS
Experimental group
Description:
Intervention: * hypnotic analgesia * active tDCS stimulation * montage: bilateral DLPFC anodal/left and cathodal/right * current:2 milliamps * time: 20 minutes
Treatment:
Other: Hypnotic analgesia + a-tDCS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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