Clinical trial NCT06255600: High-definition Transcranial Direct Current Stimulation and Chlorella Pyrenoidosa to Reduce Cardiovascular Risk
Official title: High-Definition Transcranial Direct Current Stimulation (Hd-Tdcs) and Chlorella Pyrenoidosa as an Adjuvant Treatment to Reduce Cardiovascular Risk in Patients With Long COVID
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Long Covid19
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: City University of New York
First posted: 2024-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with cardiovascular diagnosis or risk;
* Adults and elderly people (18 to 80 years old);
* Able to respond to commands and grant consent to participate in the research through the informed consent form;
* Who have post-COVID symptoms.

Exclusion Criteria:

* Patients with a clinical history of neuromuscular or cognitive instability, pregnancy and contraindications for receiving neurostimulation (such as cardiac pacemakers and metallic brain implants);
* Patients with contraindications to the use of Chlorella (gastritis, esophagitis, peptic ulcers),
* Pregnant patients, patients with stroke and tumors

Primary outcomes:
measure: Change B12 by blood analysis biochemical
timeFrame: After five week of the group of research start
Secondary outcomes:
measure: Change Methylmalonic Acid and Homocysteine
timeFrame: After five week of the group of research start
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Vanessa Meira Cintra
state: Paraíba
Study officials:
References: