NCT01874795

Brief Summary

This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable heart-failure

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

March 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

July 11, 2012

Last Update Submit

June 6, 2013

Conditions

Heart FailureChagas Disease

Keywords

Autonomic Nervous SystemNeuromodulationExercisePulmonary oxygen kineticsOxygen uptake

Outcome Measures

Primary Outcomes (1)

  • tonometry

    Applanation tonometry (AT) accurately reflects arterial stiffness method and has demonstrated a strong correlation with ventricular-vascular coupling. Increased arterial stiffness and wave reflection have also been reported in patients with systolic and diastolic HF.

    participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks

Secondary Outcomes (1)

  • Cardiorespiratory Evaluation

    participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks

Study Arms (2)

Ganglionar Electrical Stimulation

EXPERIMENTAL

TENS intervention consisted of continuous flow, symmetrical and rectangular TENS biphasic pulses. The frequency ofstimulation was 80 Hz and the pulse duration was 150 μs, with the intensity in adjusted to the point of muscle contraction.

Device: TENS

Placebo

SHAM COMPARATOR

The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.

Device: Placebo

Interventions

TENSDEVICE

Adhesive electrodes (MultiStick®, USA) were placed on each side, about 3 cm to the right and left of midline vertebral process, at C7 (Channel 1) and T4 (Channel 2).

Also known as: Ganglionar electrical stimulation
Ganglionar Electrical Stimulation
PlaceboDEVICE

The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.

Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic and Chagas disease previously diagnosticated
  • Age above 40 years old

You may not qualify if:

  • No vascular disease
  • No recent surgery
  • No recent infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Brasilia

Brasília, Federal District, 700000, Brazil

Location

Related Publications (3)

  • Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.

    PMID: 18417519BACKGROUND

  • Chiappa GR, Borghi-Silva A, Ferreira LF, Carrascosa C, Oliveira CC, Maia J, Gimenes AC, Queiroga F Jr, Berton D, Ferreira EM, Nery LE, Neder JA. Kinetics of muscle deoxygenation are accelerated at the onset of heavy-intensity exercise in patients with COPD: relationship to central cardiovascular dynamics. J Appl Physiol (1985). 2008 May;104(5):1341-50. doi: 10.1152/japplphysiol.01364.2007. Epub 2008 Mar 20.

    PMID: 18356477BACKGROUND

  • Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.

    PMID: 21796410BACKGROUND

MeSH Terms

Conditions

Heart FailureChagas DiseaseMotor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesTrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Gerson C junior, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

  • Gaspar R Chiappa, ScD

    University Federal of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 11, 2012

First Posted

June 11, 2013

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

BR(1)