Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation, Muscular Perfusion and Autonomic Response in Healthy Subjects: a Randomized, Crossover, Sham Controlled Trial.

Conditions
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Pain

Intervention / Treatment
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* Procedure: Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group<br>Needle electrical stimulation of accessory spinal nerve | Procedure: Electrical Stimulation<br>* A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;<br>* Other names: electroacupuncture;|
| Sham Comparator: Sham Group<br>Needle of accessory spinal nerve without electrical stimulation | Procedure: Electrical Stimulation<br>* A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;<br>* Other names: electroacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical Activation | The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS) | 12 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular perfusion | Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS) | 12 minutes | 
| Blood pressure | blood pressure measurement | 20 minutes | 
| Oxygen saturation | Oxygen measurement | 20 minutes | 
| Cardiac frequency | Cardiac frequency measurement | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain mechanisms, Cortical activation, fNIRS, Accessory spinal nerve, Autonomic response, Muscular perfusion