Non-invasive neurostimulation for heart failure patients
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 testing if a new type of brain stimulation can improve heart rate and exercise ability in people with heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federal University of Paraíba Academic / other |
| Locations | 1 site (João Pessoa, Paraíba) |
| Trial ID | NCT05944874 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of high-definition transcranial direct current stimulation (HD-TDCS) on heart rate variability in patients diagnosed with heart failure. Participants will undergo three sessions of stimulation targeting the left temporal cortex, with assessments conducted before and after each session. The study will also evaluate patients' performance on the six-minute walk test, alongside monitoring heart rate variability using Holter devices. The trial aims to gather data on exertion perception, dyspnea levels, distance covered, and blood pressure changes throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over eighteen years old with a clinical diagnosis of heart failure classified in functional class II and III.
Not a fit: Patients with neurological or pulmonary diseases, cognitive impairments, or physical limitations that hinder exercise protocol execution may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve heart rate variability and overall exercise capacity in heart failure patients.
How similar studies have performed: While the approach of using neurostimulation in heart failure is relatively novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
João Pessoa, Paraíba
- University Hospital Lauro Wanderley — João Pessoa, Paraíba, Brazil (Recruiting)
Study contacts
- Principal investigator: José Sr Heriston — Federal University of Paraiba
- Study coordinator: José Sr Heriston
- Email: joseheristonlima@yahoo.com.br
- Phone: +55 (83)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.