NCT03744897

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

September 21, 2017

Last Update Submit

November 22, 2018

Conditions

Pain PerceptionPain Acute

Keywords

pain perceptiontDCSHypnosiscortical activity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Change in beta waves

    60 minutes

  • Change in gamma waves

    60 minutes

  • Change in delta waves

    60 minutes

  • Change in Heat thermal threshold

    60 minutes

  • Change in Heat pain threshold

    60 minutes

  • +5 more secondary outcomes

Study Arms (4)

Hypnotic analgesia

EXPERIMENTAL

Intervention: \- Subjects will receive hypnotic analgesia

Behavioral: Hypnotic analgesia

a-tDCS

EXPERIMENTAL

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 analgesiaDevice: s-tDCS

s-tDCS

SHAM COMPARATOR

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-tDCSOther: Hypnotic analgesia + a-tDCS

Hypnotic analgesia + a-tDCS

EXPERIMENTAL

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

Interventions

Hypnotic analgesiaBEHAVIORAL

Subjects will receive hypnotic analgesia during 20 minutes

Hypnotic analgesiaa-tDCS
a-tDCSDEVICE

Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

s-tDCS
Hypnotic analgesia + a-tDCSOTHER

Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes

Hypnotic analgesia + a-tDCSs-tDCS
s-tDCSDEVICE

Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes

a-tDCS

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil

Location

Hospital de Clinicas e Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 25287554RESULT

  • 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.

    PMID: 24535464RESULT

  • 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.

    PMID: 15571771RESULT

  • 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.

    PMID: 30022928RESULT

  • 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.

    PMID: 16148743RESULT

  • 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.

    PMID: 32982393DERIVED

  • 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.

    PMID: 31297046DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wolnei Caumo, MD. PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 1. Hypnotic analgesia + a-tDCS 2. Hypnotic analgesia + s-tDCS 3. Hypnotic analgesia 4. a-tDCS
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery Department - School of Medicine - Head of HCPA Pain and Palliative Care Outpatient

Study Record Dates

First Submitted

September 21, 2017

First Posted

November 19, 2018

Study Start

July 18, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)