Cognitive Deficit, COVID-19, Fatigue, Neurophysiologic Abnormality
Conditions
Keywords
fatigue, cognitive deficits, post-covid19 syndrome
Brief summary
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTpalmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
DIETARY_SUPPLEMENTPlacebo
assumption of a placebo product 2 time/day for 8 weeks
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blind randomized placebo-controlled study
Intervention model description
Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in % of test amplitude in LICI 100 | LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration | changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in % of test amplitude in SAI 20 | SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration | changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected |
| change in LTP-like cortical plasticity | LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration | change of MEP modulation after intermittent theta burst stimulation (iTBS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes in Montreal Cognitive Assessment score | Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration | changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected |
| changes in Frontal Assessment Battery score | Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration | changes in Frontal Assessment Battery score, for evaluating the executive functions, are expected |
Countries
Italy
Outcome results
None listed