NCT03295370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2018

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

July 27, 2017

Last Update Submit

January 4, 2018

Conditions

Pain

Keywords

Pain mechanismsCortical activationfNIRSAccessory spinal nerveAutonomic responseMuscular perfusion

Outcome Measures

Primary Outcomes (1)

  • Cortical Activation

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

    12 minutes

Secondary Outcomes (4)

  • Muscular perfusion

    12 minutes

  • Blood pressure

    20 minutes

  • Oxygen saturation

    20 minutes

  • Cardiac frequency

    20 minutes

Study Arms (2)

Active Group

EXPERIMENTAL

Needle electrical stimulation of accessory spinal nerve

Procedure: Electrical Stimulation

Sham Group

SHAM COMPARATOR

Needle of accessory spinal nerve without electrical stimulation

Procedure: Electrical Stimulation

Interventions

Electrical StimulationPROCEDURE

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

Also known as: electroacupuncture
Active GroupSham Group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • right handed
  • basic education

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas e Porto Alegre (HCPA)

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

Location

Related Publications (1)

  • 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.

    PMID: 31263406DERIVED

MeSH Terms

Conditions

Pain

Interventions

Electric StimulationElectroacupuncture

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesCombined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgery Department Professor, School of Medicine UFRGS - MD. PhD.

Study Record Dates

First Submitted

July 27, 2017

First Posted

September 27, 2017

Study Start

June 13, 2017

Primary Completion

January 4, 2018

Study Completion

January 4, 2018

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

BR(1)