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

Sponsor
Federal University of Paraíba (Other)
Overall Status
Recruiting
CT.gov ID
NCT05944874
Collaborator
(none)
30
1
3
15.9
1.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: high definition transcranial direct current stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
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 treatmentThis 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:
Triple (Participant, Care Provider, Investigator)
Masking Description:
HD-TDCS applicator, six-minute walk test evaluator, and patient are blind
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 5, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • HD-tDCS
  • Experimental: 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.

    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.
    Other Names:
  • HD-tDCS
  • Experimental: 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.

    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.
    Other Names:
  • HD-tDCS
  • Outcome Measures

    Primary Outcome Measures

    1. Travelled distance [day one]

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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Lauro Wanderley João Pessoa Paraíba Brazil

    Sponsors and Collaborators

    • Federal University of Paraíba

    Investigators

    • Principal Investigator: José Sr Heriston, Federal University of Paraiba

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    José Heriston de Morais Lima, teacher, Federal University of Paraíba
    ClinicalTrials.gov Identifier:
    NCT05944874
    Other Study ID Numbers:
    • 64878922.2.0000.5188
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by José Heriston de Morais Lima, teacher, Federal University of Paraíba
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 13, 2023