Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy34 enrolled

Overview

The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid

Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatigue Cognitive Deficit COVID-19 Neurophysiologic Abnormality

Interventions

palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)DIETARY_SUPPLEMENT

assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks

PlaceboDIETARY_SUPPLEMENT

assumption of a placebo product 2 time/day for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab; * subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day; * mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission; * complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection. Exclusion Criteria: * prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions; * clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease; * anaemia; * current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study

Locations (1)

Hospital of Vipiteno-Sterzing

Sterzing, BZ, Italy

Outcomes

Primary Outcomes

changes in % of test amplitude in LICI 100

changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected

Time frame: LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration

Secondary Outcomes

changes in % of test amplitude in SAI 20

changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected

Time frame: SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration

change in LTP-like cortical plasticity

change of MEP modulation after intermittent theta burst stimulation (iTBS)

Time frame: LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration

Data from ClinicalTrials.gov

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