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

January 4, 2018 updated by: Wolnei Caumo, Hospital de Clinicas de Porto Alegre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • Hospital de Clinicas e Porto Alegre (HCPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2017

Primary Completion (Actual)

January 4, 2018

Study Completion (Actual)

January 4, 2018

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 54489816.3.0000.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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