Clinical trial NCT05311852: Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Cognitive Deficit
COVID-19
Neurophysiologic Abnormality
Keywords: fatigue
cognitive deficits
post-covid19 syndrome
Lead sponsor: Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
Sponsor class: NETWORK
Collaborators: name: I.R.C.C.S. Fondazione Santa Lucia
First posted: 2022-04-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in % of test amplitude in LICI 100
timeFrame: LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration
Secondary outcomes:
measure: changes in % of test amplitude in SAI 20
timeFrame: SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration
measure: change in LTP-like cortical plasticity
timeFrame: LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration
Other outcomes:
measure: changes in Montreal Cognitive Assessment score
timeFrame: Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration
measure: changes in Frontal Assessment Battery score
timeFrame: Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration
Locations:
city: Vipiteno
country: Italy
facility: Hospital of Vipiteno-Sterzing
state: BZ
Study officials:
affiliation: Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing
name: Leopold Saltuari, Md
role: STUDY_DIRECTOR
References: