Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255600
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-11
Brief Title:
High-definition Transcranial Direct Current Stimulation and Chlorella Pyrenoidosa to Reduce Cardiovascular Risk
Sponsor:
Federal University of Paraíba
Organization:
Federal University of Paraíba
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD-TDCS
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 5gday containing 4mcg of B12 organic pressed into tablets Registration with ANVISAMS 67273000 for five weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None