Cardiovascular DiseasesHD-TDCSNCT06255600
High-definition Transcranial Direct Current Stimulation and Chlorella Pyrenoidosa to Reduce Cardiovascular Risk
A study testing High Definition-transcranial Direct Current Stimulation and Chlorella Pyrenoidosa in people with Cardiovascular Diseases and Long Covid19, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Long Covid19
- What is being tested?
- High Definition-transcranial Direct Current Stimulation and Chlorella Pyrenoidosa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2021to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Vanessa Meira Cintra
João Pessoa, Paraíba, 58015-150
Suellen Andrade, Phd, (83) 986046032 ext. +55, suellenandrade@gmail.com
Vanessa Meira Cintra, Msc, (83) 999966528 ext. +55, vanessameiracintra@gmail.com
About this study
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
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.
Read the 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
- Being tested
- High Definition-transcranial Direct Current Stimulation, Chlorella Pyrenoidosa
- Medical subject headings
- Cardiovascular Diseases, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Definition-transcranial Direct Current StimulationOther
High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety.
Chlorella PyrenoidosaDietary supplement
functional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: High Definition-transcranial Direct Current Stimulation; Dietary Supplement: Chlorella Pyrenoidosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change B12 by blood analysis biochemical
Change B12 (above 148pmol/L)
Measured: After five week of the group of research start
Secondary outcomes (1)
Change Methylmalonic Acid and Homocysteine
Change blood levels of Methylmalonic Acid and Homocysteine (below 270nmol/L and 12mmol/L, respectively)
Measured: After five week of the group of research start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start10 Aug 2021
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- City University of New York
- Responsible party
- Principal investigator, Suellen Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255600
- Sponsor's protocol ID
- HD-tDCS/Chlorella
- Acronym
- HD-TDCS
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06255600
- Acronym / sponsor ID
- HD-TDCS / HD-tDCS/Chlorella
- Conditions
- Cardiovascular Diseases, Long Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- City University of New York
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental HD-tDCs | Experimental | Other: High Definition-transcranial Direct Current StimulationPatients 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 |
| Experimental HD-tDCS and Chlorella | Experimental | Other: High Definition-transcranial Direct Current Stimulation, Dietary Supplement: Chlorella PyrenoidosaPatients 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. |
| Experimental Chlorella | Experimental | Dietary Supplement: Chlorella PyrenoidosaPatients 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. |
| Placebo/Sham | Sham comparator | Other: High Definition-transcranial Direct Current Stimulation, Dietary Supplement: Chlorella PyrenoidosaPatients 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Definition-transcranial Direct Current StimulationHigh-Definition transcranial Direct Current Stimulation (HD-tDCS) is a neuromodulation technique, is non-invasive, targeted, safety. | Other | Experimental HD-tDCS and Chlorella, Experimental HD-tDCs, Placebo/Sham |
| Chlorella Pyrenoidosafunctional food, organically pressed into tablets (Registration with ANVISA/MS: 6.7273.000) | Dietary supplement | Experimental Chlorella, Experimental HD-tDCS and Chlorella, Placebo/Sham |
Primary outcome
Change B12 by blood analysis biochemical
Time frame: After five week of the group of research start
Change B12 (above 148pmol/L)
1 secondary outcome
Change Methylmalonic Acid and Homocysteine
Time frame: After five week of the group of research start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Definition-transcranial Direct Current Stimulation and Chlorella Pyrenoidosa in people with Cardiovascular Diseases and Long Covid19, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade, PhD (+55(83)986046032 ext. 5833, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change B12 by blood analysis biochemical (time frame: After five week of the group of research start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.