Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects
Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation, Muscular Perfusion and Autonomic Response in Healthy Subjects: a Randomized, Crossover, Sham Controlled Trial.
This randomized, crossover sham controlled trial with sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.
Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.
The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.
Studieoversikt
Detaljert beskrivelse
In recent years, there are growing evidence that many diseases such as chronic pain and psychiatric disorders can be managed with non-pharmacological techniques. The possibility of inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS). However, there are few studies on physiological mechanisms, indications and limitations of each technique.
Thus, this randomized, crossover sham controlled trial, where sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.
Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.
The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- healthy male subjects
- right handed
- basic education
Exclusion Criteria:
- contraindication to infrared technology NIRS
- brain stimulator device
- drug and alcohol abuse
- chronic disease (any);
- chronic pain condition
- tobacco use
- psychiatric disorders
- Beck Depression Inventory higher then score 12
- psychotropic drugs
- use of pain-killers or anti-inflammatories 12h previous experiment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Active Group
Needle electrical stimulation of accessory spinal nerve
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A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;
Andre navn:
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Sham-komparator: Sham Group
Needle of accessory spinal nerve without electrical stimulation
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A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cortical Activation
Tidsramme: 12 minutes
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The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)
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12 minutes
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Muscular perfusion
Tidsramme: 12 minutes
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Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)
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12 minutes
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Blood pressure
Tidsramme: 20 minutes
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blood pressure measurement
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20 minutes
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Oxygen saturation
Tidsramme: 20 minutes
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Oxygen measurement
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20 minutes
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Cardiac frequency
Tidsramme: 20 minutes
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Cardiac frequency measurement
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20 minutes
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 54489816.3.0000.5327
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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