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Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.

Effect of Melatonin and Transcranial Direct Current Stimulation (tDCS) on Neuroplasticity and the Heat-pain Detection Threshold in Healthy Subjects:Randomized, Double-blind,Crossover Trial

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02195271
Enrollment
50
Registered
2014-07-21
Start date
2014-03-31
Completion date
2014-08-31
Last updated
2014-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia Disorder, Pain

Keywords

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

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.

Detailed description

The methods are according to the CONSORT guidelines. Heat pain threshold and tolerance : Quantitative Sensory Testing (QST) will be used on a computer Peltier-based device thermode. Conditioned Pain Modulation (CPM)-task: Immerssing the non-dominant hand cold water for 1 minute. Serum Brain Derived Neurotrophic Factor (BDNF). Transcranial Magnetic Stimulation (TMS) assessment: motor threshold, motor evoked potential, Short intracortical inhibition and intracortical facilitation. Statistical analyses: Descriptive statistics, Linear and multiple regression analysis, performed with SPSS version18.0.

Interventions

DEVICETranscranial Direct Current Stimulation (tDCS)
DRUGMelatonin

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in heat-pain threshold with pain scoreBaseline, one weekHeat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)

Secondary

MeasureTime frameDescription
Change from baseline Brain-Derived neurotrophic factor (BDNF)Baseline, one week
Change from Baseline from Catastrophizing ScaleBaseline, one week
Change from baseline Inventory of state-trait anxiety ScaleBaseline, one week
Change from baseline Inventory of CopingBaseline, one week
Change from baseline of cortical excitabilityBaseline, one weekTranscranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation

Countries

Brazil

Contacts

Primary ContactWolnei Caumo, PhD
caumo@cpovo.net555133598083
Backup ContactNadia Jardim, MD
nrjs@ufpa.br555133598083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026