Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2024-09-30

Brief Summary

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This study is a clinical trial, and may also be referred to as a "before and after" study, in which all subjects receive the same treatment and their condition is checked before initiation and after various times of treatment. This study will be carried out at the Laboratory of Physiotherapy in Cardiorespiratory Research, located in the building of the postgraduate course in physiotherapy at the Health Sciences Center (CCS) of the Federal University of Parahyba (UFPB), from May 2023 to May 2020. 2024. After screening, patients will undergo assessment and anthropometric measurements. Subsequently, interventions will be carried out

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Detailed Description

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The patients will perform three sessions of HD-TDCS (stimulation, inhibition and Shan) of twenty minutes with an intensity of three milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This study is a clinical trial, and may also be called a "before and after" study, in which all subjects receive the same treatment and their condition is checked before beginning and after various moments of treatment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

HD-TDCS applicator, six-minute walk test evaluator, and patient are blind

Study Groups

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HD- TDCS (inhibition)

Patients will perform a session (inhibition) of HD-TDCS of twenty minutes with intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.

HD- TDCS (stimulation)

Patients will perform a session (stimulation) of HD-TDCS of twenty minutes with intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.

HD- TDCS (shan)

Patients will perform a twenty-minute session (SHAN) of HD-TDCS with an intensity of 3 milliamps in the left temporal cortex. Before and after each session, patients will perform the six-minute walk test. Heart rate variability (HRV) will be evaluated throughout the protocol through Holter (3-channel). At the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.

Interventions

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high definition transcranial direct current stimulation

Transcranial direct current stimulation, in recent decades, has been identified as a non-invasive tool for transiently modulating human brain activity. The technique consists of the application of a low-intensity continuous electric current, through electrodes applied to the scalp, acting in a regulatory way on the frequency of triggered action potentials, however, without interacting directly with the neurons.

Intervention Type DEVICE

Other Intervention Names

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HD-tDCS

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of heart failure;
* over eighteen years old;
* classified in functional class II and III of the New York Heart Association.

Exclusion Criteria

* Patients with neurological or pulmonary diseases;
* Patients with cognitive alterations that make it impossible to execute commands;
* with physical limitations that prevent the performance of the exercise protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No