An interventional study of High Definition-transcranial Direct Current Stimulation and Chlorella Pyrenoidosa in Cardiovascular Diseases and Long Covid19, sponsored by Federal University of Paraíba. Recruiting at 1 site in Brazil. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Treatment
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Federal University of Paraíba is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be randomly enrolled into this group. They will receive stimulation in the portion of the left primary motor cortex (M1) by HD-tDCS (lasting 20 minutes of 4x1 tDCS-HD) with anodal stimulus, twice a week for five weeks. The electric current will be supplied with an acceleration time of 30 seconds and will be maintained for 20 minutes and then reduced by 30 seconds
Other: High Definition-transcranial Direct Current Stimulation
Patients will be randomly enrolled into this group. They will receive stimulation in the portion of the left primary motor cortex (M1) by HD-tDCS (lasting 20 minutes of 4x1 tDCS-HD) with anodal stimulus, twice a week for five weeks. The electric current will be supplied with an acceleration time of 30 seconds and will be maintained for 20 minutes and then reduced by 30 seconds. In addition, they will receive functional food that will be provided in the form of 10 tablets per day of Chlorella Pyrenoidosa (5g/day) containing 4mcg of B12, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000) for five weeks.
Other: High Definition-transcranial Direct Current Stimulation · Dietary Supplement: Chlorella Pyrenoidosa
Patients will be randomly enrolled into this group. They will receive the functional food that will be provided in the form of 10 tablets per day of Chlorella Pyrenoidosa (5g/day) containing 4mcg of B12, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000) for five weeks.
Dietary Supplement: Chlorella Pyrenoidosa
Patients allocated to this group will receive a simulated 3mA current with 30 seconds of acceleration and 30 seconds of deceleration minutes of anodal HD-tDCS (4x1) for 10 sessions (twice a week in five weeks) and/or Placebo with maltodextrin (5g/day) being 10 capsules per day for five weeks.
Other: High Definition-transcranial Direct Current Stimulation · Dietary Supplement: Chlorella Pyrenoidosa
High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety.
functional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000)
Change B12 by blood analysis biochemical
Change B12 (above 148pmol/L)
Time frame: After five week of the group of research start
Change Methylmalonic Acid and Homocysteine
Change blood levels of Methylmalonic Acid and Homocysteine (below 270nmol/L and 12mmol/L, respectively)
Time frame: After five week of the group of research start
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Jun 2024, 34 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 34 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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Federal University of Paraíba