PL-PC19: Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

Sponsor

Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy (Other)

Overall Status

Completed

CT.gov ID

NCT05311852

Collaborator

I.R.C.C.S. Fondazione Santa Lucia (Other)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fatigue Cognitive Deficit COVID-19 Neurophysiologic Abnormality	Dietary Supplement: palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT) Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomized and assigned to one of two or more groups in parallel for the duration of the studyParticipants are randomized and assigned to one of two or more groups in parallel for the duration of the study

Masking:

Double (Participant, Investigator)

Masking Description:

This is a double-blind randomized placebo-controlled study

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Aug 16, 2021

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEA-LUT patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks	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 Comparator: Placebo patients were required to assume granulated placebo, 2 time/day for 8 weeks	Dietary Supplement: Placebo assumption of a placebo product 2 time/day for 8 weeks

Arm

Intervention/Treatment

Experimental: PEA-LUT

patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks

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 Comparator: Placebo

patients were required to assume granulated placebo, 2 time/day for 8 weeks

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

changes % 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 Outcome Measures

changes in FRS score [FRS was assessed two times, at enrollment and after 8 weeks of treatment duration]
changes in Fatigue Rating Scale, for evaluating percevied fatigue on a numerical rating, scale (0, no fatigue; 10, extreme fatigue) are expected
changes in MoCA score [MoCA was assessed at enrollment and at the end of the treatment]
changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected
changes 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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