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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- changes in % of test amplitude in LICI 100
研究概览
简要总结
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind randomized placebo-controlled study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study
结局指标
主要结局
changes in % of test amplitude in LICI 100
时间窗: 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
次要结局
- change in LTP-like cortical plasticity(LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration)
- changes in % of test amplitude in SAI 20(SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration)
研究者
Paola Ortelli
PsyD, Principal Investigator
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy