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

NCT05944874 | Unknown

• 1 other identifier: 64878922.2.0000.5188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Travelled distance

  To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs

  day one

• heart rate variability

  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

  day one

Study Arms (3)

HD- TDCS (inhibition)

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation

HD- TDCS (stimulation)

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation

HD- TDCS (shan)

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation

Interventions

high definition transcranial direct current stimulation 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.

Also known as: HD-tDCS

HD- TDCS (inhibition); HD- TDCS (shan); HD- TDCS (stimulation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

University Hospital Lauro Wanderley

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• José Sr Heriston

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Sr Heriston

CONTACT

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

Arthur Sr Bruno

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: HD-TDCS applicator, six-minute walk test evaluator, and patient are blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teacher

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 13, 2023
• Study Start: May 5, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)