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

Heart Failure Clinical Trial

— HD-tDCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944874
• Other study ID #: 64878922.2.0000.5188
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Federal University of Paraíba
• Contact: José Sr Heriston
• Phone: +55 (83)
• Email: joseheristonlima[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	University Hospital Lauro Wanderley	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Travelled distance	To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs	day one
Primary	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