Heart FailureHD-tDCSNCT05944874
Effect of Non-invasive Neurostimulation on Variability OF HEART RATE IN PATIENTS WITH HEART FAILURE.
A study testing high definition transcranial direct current stimulation in people with Heart Failure, run by Federal University of Paraíba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- high definition transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of heart failure;
- over eighteen years old;
- classified in functional class II and III of the New York Heart Association.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital Lauro Wanderley
João Pessoa, Paraíba
Emanuel, Kaio, +55 (83) 99946-1332, kaioemanuelnunes@gmail.com
About this study
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
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.
- Conditions
- Heart Failure
- Being tested
- high definition transcranial direct current stimulation
- Keywords
- Heart failure, transcranial direct current stimulation, six minute walk test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high definition transcranial direct current stimulationDevice
Also called HD-tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: high definition transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Travelled distance
To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs
Measured: 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
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start5 May 2023
- Primary completionMay 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Heriston de Morais Lima, Federal University of Paraíba
- Investigators
- José Sr Heriston, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944874
- Sponsor's protocol ID
- 64878922.2.0000.5188
- Acronym
- HD-tDCS
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05944874
- Acronym / sponsor ID
- HD-tDCS / 64878922.2.0000.5188
- Conditions
- Heart Failure
- Keywords
- Heart failure, transcranial direct current stimulation, six minute walk test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| HD- TDCS (inhibition) | Experimental | Device: high definition transcranial direct current stimulationPatients 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. |
| HD- TDCS (stimulation) | Experimental | Device: high definition transcranial direct current stimulationPatients 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. |
| HD- TDCS (shan) | Experimental | Device: high definition transcranial direct current stimulationPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of heart failure;
- over eighteen years old;
- classified in functional class II and III of the New York Heart Association.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high definition transcranial direct current stimulationAlso: HD-tDCSTranscranial 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. | Device | HD- TDCS (inhibition), HD- TDCS (shan), HD- TDCS (stimulation) |
Primary outcome
Travelled distance
Time frame: day one
To analyze the distance walked by these patients after the six-minute walk test after the application of HD-Tdcs
heart rate variability
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Sr Heriston principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high definition transcranial direct current stimulation in people with Heart Failure, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Sr Heriston (+55 (83) ext. 99664-1600, joseheristonlima@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Travelled distance (time frame: day one). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.