NCT06255600

High-definition Transcranial Direct Current Stimulation and Chlorella Pyrenoidosa to Reduce Cardiovascular Risk

High-Definition Transcranial Direct Current Stimulation (Hd-Tdcs) and Chlorella Pyrenoidosa as an Adjuvant Treatment to Reduce Cardiovascular Risk in Patients With Long COVID

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Recent investigations have shown that of the patients who were affected by SARCov2 have remained with persistent symptoms in a high proportion. In these considerations, the literature has suggested nomenclatures such as "post-COVID-19" and "chronic COVID-19", "long -COVID" and Post-Covid Syndrome for patients recovered from SARCov2 reporting persistent symptoms and signs for weeks to months after resolution of the acute infection. Furthermore, there may be cardiovascular complications in affected patients, the consequences of which can lead to muscle contractility disorders, vascular insufficiency, cardiac arrest, reinforcing the need for controlled, randomized studies, as well as follow-up and monitoring of these. Furthermore, cardiovascular diseases (CVD) are part of the health problems that lead to the most deaths in the world, they also lead to a high proportion of hospital admissions, due to the worsening of the pathology and a higher incidence in the elderly population. The worsening of CVD conditions leads to inadequate food consumption at the hospital level, causing changes in several nutrients, including vitamin B12. The reduction in B12 levels leads to changes in several systems, including the cardiovascular system, and due to the increase in homocysteine and the triggering of the inflammatory cascade. Studies indicate that B12 supplementation through Chlorella (microalgae - functional food) reduced cardiovascular risk and modulated the inflammatory cascade. In combination, neurostimulation has presented aspects that promote pain neuromodulation, due to the improvement of respiratory patterns and inflammatory modulation. More specifically, there is a protocol with promoting findings, this being HD-tDCS. In this sense, this research aims to evaluate the effects of HD-tDCS and the consumption of Chlorella Pyrenoidosa to improve B12 levels in patients with cardiovascular risk post-COVID-19.

Detailed description

This study is an open label research, clinical trial, double blind, placebo controlled, and randomized, involving assistance to patients at risk of cardiovascular disease, in outpatient care (Continue Caring Project). Included in the research are adults and elderly participants at cardiovascular risk, whose initial diagnosis for hospitalization was due to COVID-19 and at the hospital level those admitted for treatment in the Intensive Care Unit or ward with heart disease who are eligible for neurostimulation by HD-tDCS. Patients will be randomly allocated into an experimental and control group for HD-tDCS and also to receive the functional food. The protocol will be HD-tDCS (lasting 20 minutes of 4x1 tDCS-HD) positioning the central electrode in the left primary motor cortex (M1) with anodal stimulus, twice a week; nutritional monitoring; collection of laboratory tests (at the beginning and end of treatment) and the group that will receive the functional food will be provided with 10 tablets of Chlorella Pyrenoidosa (5g/day) containing 4mcg of B12, organic pressed into tablets (Registration with ANVISA/MS : 6,7273,000) for five weeks.

Conditions

• Cardiovascular Diseases
• Long Covid19

Interventions

Type	Name	Description
OTHER	High Definition-transcranial Direct Current Stimulation	High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety.
DIETARY_SUPPLEMENT	Chlorella Pyrenoidosa	functional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000)

Timeline

• Start date: 2021-08-10
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2024-02-13
• Last updated: 2024-03-05

Locations

1 site across 1 country: Brazil