Evaluation of the Potentiating Effect of tDCS on Opioid Analgesia of Pain Threshold in Humans

NCT02432677 | Unknown Phase 2

• 1 other identifier: 14-0217
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the potential additive effect of tDCS compared to placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in healthy volunteers .

Conditions

Acute Pain

Keywords

tDCS; Opioid; Pain; Pain threshold

Outcome Measures

Primary Outcomes (1)

• Thresholds of pain to the cold pressor test (CPT)

  20min

Secondary Outcomes (7)

• Serum levels of BDNF

  20min

• Intensity of electrical brain activity in the bi-spectral index (BIS)

  60min

• Sedation level in the visual analogue scale (VAS)

  60min

• Temperature of tolerance to the thermal stimulus (TTTS)

  20min

• Conditioned pain modulation (CPM)

  20min

Study Arms (4)

Remifentanil + Active tDCS

EXPERIMENTAL

* tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes. * Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.

Drug: Remifentanil; Device: Active tDCS

Placebo + Active tDCS

OTHER

* tDCS session: the procedure will initiate by placing an anode electrode on the primary motor cortex (contralateral to the dominant cortex) and the cathode electrode on the contralateral supra-orbital region. The current employed is 2mA of transcranial direct-current stimulation administered for 20 minutes. * Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.

Device: Active tDCS; Drug: Placebo

Remifentanil + Sham tDCS

OTHER

* Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session. * Remifentanil - 0,06mcg.kg.min - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.

Drug: Remifentanil; Device: Sham tDCS

Placebo + Sham tDCS

OTHER

* Sham tDCS: consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session. * Placebo: Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.

Device: Sham tDCS; Drug: Placebo

Interventions

Remifentanil DRUG

Remifentanil (IV infusion): 0,06mcg.kg.min. The infusion starts 10min before tDCSThe infusion will be stopped in the event of: a decrease in respiratory rate below 7 breaths / min, a peripheral oxygen saturation below 85%, a lower heart rate of 40 beats per minute, a lower mean arterial pressure of 60 mmHg, sedation causing inadequate management switch stimuli tests and occurrence of vomiting.

Remifentanil + Active tDCS; Remifentanil + Sham tDCS

Active tDCS DEVICE

The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA (milliampere) current.

Also known as: transcranial direct current stimulation

Placebo + Active tDCS; Remifentanil + Active tDCS

Sham tDCS DEVICE

The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.

Also known as: Sham - transcranial direct current stimulation

Placebo + Sham tDCS; Remifentanil + Sham tDCS

Placebo DRUG

Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.

Placebo + Active tDCS; Placebo + Sham tDCS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Healthy
• Without medication
• Sign the informed consent

You may not qualify if:

• Patients who did not understand the Portuguese
• Acute or chronic pain conditions
• Medical or psychiatric disorders
• History of sleep disorders (apnea, hypersomnia, somnambulism…)
• History of alcohol or substance abuse
• Neurological disorder
• Use of anti-inflammatory drugs, steroids and non-steroids, opioid and non-opioid analgesics, psychiatric medications, anticonvulsants, alpha and beta blockers
• Traumatic brain injury
• Neurosurgery
• Metallic implant in the brain

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas e Porto Alegre (HCPA)

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

RECRUITING

Related Publications (1)

• Braulio G, Passos SC, Leite F, Schwertner A, Stefani LC, Palmer ACS, Torres ILS, Fregni F, Caumo W. Effects of Transcranial Direct Current Stimulation Block Remifentanil-Induced Hyperalgesia: A Randomized, Double-Blind Clinical Trial. Front Pharmacol. 2018 Feb 19;9:94. doi: 10.3389/fphar.2018.00094. eCollection 2018.

  PMID: 29515438 DERIVED

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Remifentanil; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, MD, P.h.D

  Hospital de Clinicas de Porto Alegre - UFRGS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilberto Braulio, MD

CONTACT

+555183008300; gbraulio@hcpa.ufrgs.br

Wolnei Caumo, MD, P.h.D

CONTACT

+55 51 99813977; caumo@cpovo.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 4, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 4, 2015

Record last verified: 2015-04

Locations

BR (1)