A Phase 4 interventional study of electroencephalogram biofeedback and electrical brain stimulation in COVID-19 Vaccine Adverse Reaction, sponsored by Pachankis, Yang I., M.D.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Pachankis, Yang I., M.D. · Phase 4, Interventional, and Treatment
Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.
It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. GABA A receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. Benzodiazepines (BZDs) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at various GABA receptors throughout the central nervous system (CNS). Alprazolam, a type of BZD, was tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process.
Even though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. The study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.
This is the only study on the registry with Pachankis, Yang I., M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: electroencephalogram biofeedback · Device: electrical brain stimulation · Device: ultra-low frequency transcranial magnetic stimulation · Drug: Sertraline Hydrochloride · Drug: Clonazepam · Drug: Alprazolam · Drug: Metoprolol · Drug: Olanzapine · Drug: Pravastatin Sodium 20 MG · Drug: Sacubitril Valsartan Sodium Hydrate
EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.
Also known as: EB
EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.
Also known as: EBS
ULF-TMS is conducted mainly for the left side of the participant's brain for 20 minutes per section per day in the primary efficacy endpoint.
Also known as: ULF-TMS
Sertraline is taken in the morning for 150 mg per day.
Also known as: SSRI
Clonazepam is taken in the morning for 1 mg per day.
Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.
Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.
Also known as: beta blocker
Olanzapine is taken throughout the trial with 7.5 mg per night at first, and increases to 10 mg per night after the cocktail therapy.
Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.
Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.
Also known as: ARNI
Changes in Leukocyte and Components' Quantities
All white blood cells are evaluated.
Time frame: 24 days
Changes in Leukocyte Components' Ratios
All white blood cells are evaluated.
Time frame: 24 days
Quantity Changes in Megakaryocyte-Erythroid Progenitor
Time frame: 24 days
Changes in Hemoglobin Distribution
Time frame: 24 days
Changes in Mean Corpuscular Hemoglobin
Time frame: 24 days
Changes in Hematocrit
Time frame: 24 days
Changes in Plateletcrit
Time frame: 24 days
Red cell Distribution Width Coefficient of Variation
Time frame: 24 days
Changes in Particulate Matter Sizes
Time frame: 24 days
Changes in Total Lipid Quantities
Time frame: 24 days
Changes in Apolipoproteina
Time frame: 24 days
Changes in Lipoprotein (a)
Time frame: 24 days
Blood Pressure Changes
Recorded systolic and diastolic blood pressures' changes before and after medication each day.
Time frame: 24 days
Heart Rate Changes
Heart rate changes before and after medication each day.
Time frame: 24 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD will be shared on Zenodo repository.
Supporting information: Study protocol, Icf
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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