Clinical trial NCT03295370: Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain mechanisms
Cortical activation
fNIRS
Accessory spinal nerve
Autonomic response
Muscular perfusion
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cortical Activation
timeFrame: 12 minutes
Secondary outcomes:
measure: Muscular perfusion
timeFrame: 12 minutes
measure: Blood pressure
timeFrame: 20 minutes
measure: Oxygen saturation
timeFrame: 20 minutes
measure: Cardiac frequency
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas e Porto Alegre (HCPA)
state: Rio Grande Do Sul
Study officials:
References:
citation: Bandeira JS, Antunes LDC, Soldatelli MD, Sato JR, Fregni F, Caumo W. Functional Spectroscopy Mapping of Pain Processing Cortical Areas During Non-painful Peripheral Electrical Stimulation of the Accessory Spinal Nerve. Front Hum Neurosci. 2019 Jun 13;13:200. doi: 10.3389/fnhum.2019.00200. eCollection 2019.