Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

Study Overview
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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.

Official Title
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Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population

Conditions
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Heart Failure, Chagas Disease

Intervention / Treatment
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* Device: TENS
* Device: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ganglionar Electrical Stimulation<br>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<br>* 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).<br>* Other names: Ganglionar electrical stimulation;|
| Sham Comparator: Placebo<br>The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current. | Device: Placebo<br>* The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory Evaluation | Cardiopulmonary exercise testing (CPX) is a highly reliable and valid approach to assessing aerobic performance. It is a well-accepted assessment technique in the HF population with American and European associations endorsing its use. CPX is most often performed on a treadmill or cycle ergometer using ramping protocols and the addition of ventilatory expired gas analysis to the standard exercise test enables measurement of oxygen consumption (VO2), carbon dioxide production (VCO2) and minute ventilation (VE) over time. Moreover, CPX provides a host of variables that are predictive of adverse events in HF patients, including peak VO2, the VE/VCO2 slope and the oxygen uptake efficiency slope (OUES). | participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake