ClinicalTrials.gg
RecruitingNCT05944874HD-tDCSUpdated Jul 13, 2023

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

An interventional study of high definition transcranial direct current stimulation in Heart Failure, sponsored by Federal University of Paraíba. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Heart Failure

Browse trials for

Keywords

  • Heart failure
  • transcranial direct current stimulation
  • six minute walk test
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 30 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Federal University of Paraíba is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • 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

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.

    Also known as: HD-tDCS

06

What researchers measure

Primary outcomes

  1. Travelled distance

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

    Time frame: day one

  2. 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

    Time frame: day one

07

Study locations

1 of 1 sites recruiting
  • University Hospital Lauro Wanderley
    João Pessoa, Paraíba, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05944874
Lead sponsor
Federal University of Paraíba
Responsible party
José Heriston de Morais Lima (teacher, Federal University of Paraíba) — Principal investigator
First posted
Jul 13, 2023
Start date
May 5, 2023
Primary completion
May 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jul 13, 2023

Study contacts

José Sr Heriston
Contact
joseheristonlima@yahoo.com.br
+55 (83) ext. 99664-1600
Arthur Sr Bruno
Contact
joseheristonlima@yahoo.com.br
+55 (83) ext. 99664-1600
José Sr Heriston
principal investigator · Federal University of Paraiba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion