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

Effect of Non-invasive Neurostimulation on Variability of Heart Rate During the Six-minute Walk Test of Patients With Heart Failure: a Double-blinded Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05944874

Acronym

HD-tDCS

Enrollment

Registered

2023-07-13

Start date

2023-05-05

Completion date

2024-09-30

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, transcranial direct current stimulation, six minute walk test

Brief summary

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

Detailed description

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.

Interventions

DEVICEhigh 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Travelled distance	day one	To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs
heart rate variability	day one	To evaluate the effects of HD-TDCS on the left temporal lobe - T3 on heart rate variability during the six-minute walk test in patients with heart failure

Countries

Brazil

Contacts

Primary ContactJosé Sr Heriston

joseheristonlima@yahoo.com.br+55 (83)

Backup ContactArthur Sr Bruno