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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
RS
-
Porto Alegre, RS, Brasilien, 900035-903
- Rekrytering
- Hospital de Clinicas de Porto Alegre
-
Kontakt:
- Wolnei Caumo
- Telefonnummer: 555133590083
- E-post: caumo@cpovo.net
-
Underutredare:
- Nadia Jardim, MD, Msc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Melatonin
0,25mg/Kg sl before tDCS
|
|
|
Experimentell: tDCS
Transcranial direct current stimulation once time.
Dose 2 mA, 20 seconds.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in heat-pain threshold with pain score
Tidsram: Baseline, one week
|
Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
|
Baseline, one week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline Brain-Derived neurotrophic factor (BDNF)
Tidsram: Baseline, one week
|
Baseline, one week
|
|
|
Change from Baseline from Catastrophizing Scale
Tidsram: Baseline, one week
|
Baseline, one week
|
|
|
Change from baseline Inventory of state-trait anxiety Scale
Tidsram: Baseline, one week
|
Baseline, one week
|
|
|
Change from baseline Inventory of Coping
Tidsram: Baseline, one week
|
Baseline, one week
|
|
|
Change from baseline of cortical excitability
Tidsram: Baseline, one week
|
Transcranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation
|
Baseline, one week
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Wolnei Caumo, Hospital de Clinicas de Porto Alegre - UFRGS
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 130155
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