Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.

NCT02195271 | Unknown Phase 2 DMC

• 1 other identifier: 130155
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is associated with a wide range of diseases and their social consequences is a public health problem. With the progress of neuroscience and studies on the plasticity of the central nervous system, it has been provided a better understanding of the neurobiological mechanisms of pain. The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both in physiological and pathological situations, with modulating effects on the process of nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and GABAergic, exerting anti-inflammatory action, analgesic activity among others. The advent of neuromodulation techniques such as transcranial direct current stimulation (tDCS), which promote changes in neuronal activity and signaling to be effective in conditions of chronic pain by attenuating changes in cortical excitability. There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus, considering the potential for each isolated intervention and the lack of knowledge of their combined effect, the authors propose the present study to investigate the effect of this combination on the heat-pain detection threshold and the neuroplasticity in the healthy subjects.

Conditions

Analgesia Disorder; Pain

Keywords

Melatonin; Transcranial Direct Current Stimulation; Neuroplasticity; Analgesia; Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in heat-pain threshold with pain score

  Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)

  Baseline, one week

Secondary Outcomes (5)

• Change from baseline Brain-Derived neurotrophic factor (BDNF)

  Baseline, one week

• Change from Baseline from Catastrophizing Scale

  Baseline, one week

• Change from baseline Inventory of state-trait anxiety Scale

  Baseline, one week

• Change from baseline Inventory of Coping

  Baseline, one week

• Change from baseline of cortical excitability

  Baseline, one week

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

0,25mg/Kg sl before tDCS

Drug: Melatonin

tDCS

EXPERIMENTAL

Transcranial direct current stimulation once time. Dose 2 mA, 20 seconds.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

tDCS

Melatonin DRUG

Melatonin

Eligibility Criteria

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

You may qualify if:

• Male 18-40 years old
• 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 alcohol or substance abuse
• Neurological disorder
• Use of medications affect in the central nervous system
• Traumatic brain injury
• Neurosurgery
• Metallic implant in the brain

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 900035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Transcranial Direct Current Stimulation; Melatonin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Wolnei Caumo

  Hospital de Clinicas de Porto Alegre - UFRGS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolnei Caumo, PhD

CONTACT

555133598083; caumo@cpovo.net

Nadia Jardim, MD

CONTACT

555133598083; nrjs@ufpa.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: July 21, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

BR (1)