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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
RS
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Porto Alegre, RS, Brasil, 900035-903
- Rekruttering
- Hospital de Clinicas de Porto Alegre
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Ta kontakt med:
- Wolnei Caumo
- Telefonnummer: 555133590083
- E-post: caumo@cpovo.net
-
Underetterforsker:
- Nadia Jardim, MD, Msc
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Melatonin
0,25mg/Kg sl before tDCS
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Eksperimentell: tDCS
Transcranial direct current stimulation once time.
Dose 2 mA, 20 seconds.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in heat-pain threshold with pain score
Tidsramme: Baseline, one week
|
Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)
|
Baseline, one week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Brain-Derived neurotrophic factor (BDNF)
Tidsramme: Baseline, one week
|
Baseline, one week
|
|
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Change from Baseline from Catastrophizing Scale
Tidsramme: Baseline, one week
|
Baseline, one week
|
|
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Change from baseline Inventory of state-trait anxiety Scale
Tidsramme: Baseline, one week
|
Baseline, one week
|
|
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Change from baseline Inventory of Coping
Tidsramme: Baseline, one week
|
Baseline, one week
|
|
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Change from baseline of cortical excitability
Tidsramme: Baseline, one week
|
Transcranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation
|
Baseline, one week
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Wolnei Caumo, Hospital de Clinicas de Porto Alegre - UFRGS
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 130155
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