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

COVID-19 Clinical Trial

— PL-PC19  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311852
• Other study ID #: PEA-LUT-in-Post-Covid-19
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2022
• Source: Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction
• COVID-19
• Fatigue
• Neurophysiologic Abnormality

Intervention

Dietary Supplement:
• palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
• Placebo
assumption of a placebo product 2 time/day for 8 weeks

Locations

Country	Name	City	State
Italy	Hospital of Vipiteno-Sterzing	Vipiteno	BZ

Sponsors (2)

Lead Sponsor	Collaborator
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy	I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

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