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| Name | Class |
|---|---|
| I.R.C.C.S. Fondazione Santa Lucia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA-LUT | Experimental | patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks |
|
| Placebo | Placebo Comparator | patients were required to assume granulated placebo, 2 time/day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| change in LTP-like cortical plasticity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| changes in Frontal Assessment Battery score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopold Saltuari, Md | Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Vipiteno-Sterzing | Sterzing | BZ | 39049 | Italy |
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Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study
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This is a double-blind randomized placebo-controlled study
| Placebo | Dietary Supplement | assumption of a placebo product 2 time/day for 8 weeks |
|
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 |
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 |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D003072 | Cognition Disorders |
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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