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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
high definition transcranial direct current stimulation
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, transcranial direct current stimulation, six minute walk test

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Lauro WanderleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HD- TDCS (inhibition)

HD- TDCS (stimulation)

HD- TDCS (shan)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
July 12, 2023
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT05944874
Brief Title
Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, transcranial direct current stimulation, six minute walk test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
HD-TDCS applicator, six-minute walk test evaluator, and patient are blind
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HD- TDCS (inhibition)
Arm Type
Experimental
Arm Description
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.
Arm Title
HD- TDCS (stimulation)
Arm Type
Experimental
Arm Description
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.
Arm Title
HD- TDCS (shan)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
high definition transcranial direct current stimulation
Other Intervention Name(s)
HD-tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Travelled distance
Description
To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs
Time Frame
day one
Title
heart rate variability
Description
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
Time Frame
day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Sr Heriston
Phone
+55 (83)
Ext
99664-1600
Email
joseheristonlima@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Sr Bruno
Phone
+55 (83)
Ext
99664-1600
Email
joseheristonlima@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Sr Heriston
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Lauro Wanderley
City
João Pessoa
State/Province
Paraíba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuel, Kaio
Phone
+55 (83) 99946-1332
Email
kaioemanuelnunes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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