Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

NCT ID: NCT01874795

Last Updated: 2013-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older, Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups: TENS and placebo (same stimulus without electrical output) with 48 hrs between the interventions.

Conditions

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Heart Failure Chagas Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ganglionar Electrical Stimulation

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.

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

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).

Placebo

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

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DEVICE

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

Interventions

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TENS

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).

Intervention Type DEVICE

Placebo

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

Intervention Type DEVICE

Other Intervention Names

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Ganglionar electrical stimulation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No vascular disease
* No recent surgery
* No recent infections
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Gerson Cipriano Jr

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerson C junior, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Gaspar R Chiappa, ScD

Role: PRINCIPAL_INVESTIGATOR

University Federal of Rio Grande do Sul

Locations

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University of Brasilia

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 18417519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18356477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21796410 (View on PubMed)

Other Identifiers

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071/2011

Identifier Type: -

Identifier Source: org_study_id

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