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| Name | Class |
|---|---|
| City University of New York | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental HD-tDCs | Experimental | 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 |
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| Experimental HD-tDCS and Chlorella | Experimental | 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. |
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| Experimental Chlorella | Experimental | 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. |
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| Placebo/Sham |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Definition-transcranial Direct Current Stimulation | Other | High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change B12 by blood analysis biochemical | Change B12 (above 148pmol/L) | After five week of the group of research start |
| Measure | Description | Time Frame |
|---|---|---|
| Change Methylmalonic Acid and Homocysteine | Change blood levels of Methylmalonic Acid and Homocysteine (below 270nmol/L and 12mmol/L, respectively) | After five week of the group of research start |
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Inclusion Criteria:
Exclusion Criteria:
Adults and older adults
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suellen Andrade, PhD | Contact | +55(83)986046032 | 5833 | suellenandrade@gmail.com |
| Vanessa Meira Cintra, Msc | Contact | +55(83)999966528 | 5511 | vanessameiracintra@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanessa Meira Cintra | Recruiting | João Pessoa | ParaÃba | 58015-150 | Brazil |
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Experimental group: Experimental group: Patients allocated to this group will receive a current of 3mA for 20 minutes of anodal HD-tDCS (4x1) for 10 sessions (twice a week in five weeks) and/or Chlorella Pyrenoidosa (5g/day), receiving 10 tablets per day for five weeks.
Placebo/Sham Group: 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.
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The research includes the responsible researcher, assistant and collaborator. Collaborating Researcher is responsible for applying the technique to the patient, knowing which stimulus will be true or placebo. He must apply the research tools and fill out the forms. Alert the main researcher and assistant regarding signs and symptoms in patients resulting from adverse effects.
In this way, the patient and the collaborating researcher are blind.
| Sham Comparator |
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. |
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| Chlorella Pyrenoidosa | Dietary Supplement | functional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000) |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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