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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295370
• Other study ID #: 54489816.3.0000.5327
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: January 4, 2018
• Start date: June 13, 2017
• Est. completion date: January 4, 2018

Study information

• Verified date: January 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Electrical Stimulation
A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas e Porto Alegre (HCPA)	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Activation	The metabolic activation of motor cortex and dorsolateral prefrontal cortex , measured through infrared spectroscopy (fNIRS)	12 minutes
Secondary	Muscular perfusion	Muscular perfusion of trapezius muscle, peripherally measured through infrared spectroscopy (fNIRS)	12 minutes
Secondary	Blood pressure	blood pressure measurement	20 minutes
Secondary	Oxygen saturation	Oxygen measurement	20 minutes
Secondary	Cardiac frequency	Cardiac frequency measurement	20 minutes