Skip to content

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03295370
Enrollment
14
Registered
2017-09-27
Start date
2017-06-13
Completion date
2018-01-04
Last updated
2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain mechanisms, Cortical activation, fNIRS, Accessory spinal nerve, Autonomic response, Muscular perfusion

Brief summary

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

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.

Interventions

PROCEDUREElectrical Stimulation

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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cortical Activation12 minutesThe metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)

Secondary

MeasureTime frameDescription
Muscular perfusion12 minutesMuscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)
Blood pressure20 minutesblood pressure measurement
Oxygen saturation20 minutesOxygen measurement
Cardiac frequency20 minutesCardiac frequency measurement

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026