COVID-19 Clinical Trial
— PL-PC19Official title:
Effects of Palmitoylethanolamide Co-ultramicronized With Luteoline (Pea-lut) on Frontal Lobe Functions and GABAergic Transmission in Long Covid Patients. An 8-week Randomized Controlled Trial.
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid
Status | Completed |
Enrollment | 34 |
Est. completion date | March 15, 2022 |
Est. primary completion date | February 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Hospital of Vipiteno-Sterzing | Vipiteno | BZ |
Lead Sponsor | Collaborator |
---|---|
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy | I.R.C.C.S. Fondazione Santa Lucia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | changes in Montreal Cognitive Assessment score | changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected | Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration | |
Other | changes in Frontal Assessment Battery score | changes in Frontal Assessment Battery score, for evaluating the executive functions, are expected | Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration | |
Primary | changes in % of test amplitude in LICI 100 | changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected | LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration | |
Secondary | 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 | SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration | |
Secondary | change in LTP-like cortical plasticity | change of MEP modulation after intermittent theta burst stimulation (iTBS) | LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration |
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