Clinical trial NCT02432677: Evaluation of the Potentiating Effect of tDCS on Opioid Analgesia of Pain Threshold in Humans
Official title: Evaluation of the Potentiating Effect of Transcranial Direct Current Stimulation (tDCS) on Opioid Analgesia of Pain Threshold in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Pain
Keywords: tDCS
Opioid
Pain
Pain threshold
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Thresholds of pain to the cold pressor test (CPT)
timeFrame: 20min
Secondary outcomes:
measure: Serum levels of BDNF
timeFrame: 20min
measure: Intensity of electrical brain activity in the bi-spectral index (BIS)
timeFrame: 60min
measure: Sedation level in the visual analogue scale (VAS)
timeFrame: 60min
measure: Temperature of tolerance to the thermal stimulus (TTTS)
timeFrame: 20min
measure: Conditioned pain modulation (CPM)
timeFrame: 20min
measure: Threshold of pain to the thermal stimulus (TT)
timeFrame: 20min
measure: Hemodynamic changes of brain using fNIRSNear-infrared spectroscopy (NIRS)
timeFrame: 60
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas e Porto Alegre (HCPA)
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre - UFRGS
name: Wolnei Caumo, MD, P.h.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.