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Completed

NCT Number: NCT03295370

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas e Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation

Procedure

A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;

Other names: electroacupuncture

Primary outcomes

  1. Cortical Activation

    Time frame: 12 minutes

    The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)

Secondary outcomes

  1. Muscular perfusion

    Time frame: 12 minutes

    Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)

  2. Blood pressure

    Time frame: 20 minutes

    blood pressure measurement

  3. Oxygen saturation

    Time frame: 20 minutes

    Oxygen measurement

  4. Cardiac frequency

    Time frame: 20 minutes

    Cardiac frequency measurement

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2017
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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