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

Acute Pain Clinical Trial

Official title:

Evaluation of the Potentiating Effect of Transcranial Direct Current Stimulation (tDCS) on Opioid Analgesia of Pain Threshold in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432677
• Other study ID #: 14-0217
• Status: Recruiting
• Phase: Phase 2
• First received: April 6, 2015
• Last updated: April 28, 2015
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Gilberto Braulio, MD
• Phone: +555183008300
• Email: gbraulio[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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 .

Description:

Pain is a prevalent symptom in medicine and the role of various opioids is valuable in the treatment of moderate to severe pain. Several technologies of brain stimulation , including transcranial direct current stimulation ( tDCS) are emerging as therapeutic options for many pain conditions. The effect of tDCS was demonstrated in sensory perception , decreasing the threshold for acute pain in healthy volunteers and in various chronic pain conditions . There is evidence about the use of tDCS with the participation through many mechanisms in cortical modulation , including the regulation of neurotransmitters, including opioids. In the context of neurostimulation, opioidergic system and cortical pain modulation, emerge the hypothesis of a possible potentiating effect of tDCS on clinical application of opioid analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male

• Healthy

• Without medication

• Sign the informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Remifentanil
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.

Device:
• Active tDCS
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.
• Sham tDCS
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.

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

Locations

Country	Name	City	State
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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thresholds of pain to the cold pressor test (CPT)		20min	No
Secondary	Serum levels of BDNF		20min	No
Secondary	Intensity of electrical brain activity in the bi-spectral index (BIS)		60min	No
Secondary	Sedation level in the visual analogue scale (VAS)		60min	No
Secondary	Temperature of tolerance to the thermal stimulus (TTTS)		20min	No
Secondary	Conditioned pain modulation (CPM)	A nociceptive tonic conditioning stimulus - immersion of the non-dominant hand in cold water (0°C for 1 minute) - will be applied concomitant to the progressive thermal stimulus in the dominant forearm as applied in the QST pattern until it reaches the 6/10 pain temperature previously determined by the participant.	20min	No
Secondary	Threshold of pain to the thermal stimulus (TT)		20min	No
Secondary	Hemodynamic changes of brain using fNIRSNear-infrared spectroscopy (NIRS)	The vascular response will be assessed using functional near infrared spectroscopy (fNIRS). Emerging technique that allows the functional mapping of the brain, with a better understanding of the neuro-vascular coupling, the neurophysiological fluctuations and cerebral hemodynamics.	60	No