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

NCT06255600 | Recruiting

• 1 other identifier: HD-tDCS/Chlorella
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Long Covid19

Outcome Measures

Primary Outcomes (1)

• Change B12 by blood analysis biochemical

  Change B12 (above 148pmol/L)

  After five week of the group of research start

Secondary Outcomes (1)

• Change Methylmalonic Acid and Homocysteine

  After five week of the group of research start

Study Arms (4)

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

Other: High Definition-transcranial Direct Current Stimulation

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.

Other: High Definition-transcranial Direct Current Stimulation; Dietary Supplement: Chlorella Pyrenoidosa

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.

Dietary Supplement: Chlorella Pyrenoidosa

Placebo/Sham

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.

Other: High Definition-transcranial Direct Current Stimulation; Dietary Supplement: Chlorella Pyrenoidosa

Interventions

High Definition-transcranial Direct Current Stimulation OTHER

High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety.

Experimental HD-tDCS and Chlorella; Experimental HD-tDCs; Placebo/Sham

Chlorella Pyrenoidosa DIETARY_SUPPLEMENT

functional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000)

Experimental Chlorella; Experimental HD-tDCS and Chlorella; Placebo/Sham

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: Adults and older adults
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Paraíba: lead
• City University of New York: collaborator

Study Sites (1)

Vanessa Meira Cintra

João Pessoa, Paraíba, 58015-150, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Suellen Andrade, PhD

CONTACT

+55(83)986046032; suellenandrade@gmail.com

Vanessa Meira Cintra, Msc

CONTACT

+55(83)999966528; vanessameiracintra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Suellen Marinho Andrade

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 13, 2024
• Study Start: August 10, 2021
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)