Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance: A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Neuroinflammation Assessment
研究概览
简要总结
This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for all groups:
- •Age between 18 and 65 years.
- •Inclusion criteria for the PPPD-glialia group:
- •Diagnosis of PPPD;
- •Recovery from COVID-19 infection or absence of previous infection.
- •Inclusion criteria for the PPPD-placebo group:
- •Diagnosis of PPPD;
- •Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).
排除标准
- •for all PPPD-group:
- •Presence of concurrent neurological and otological disorders other than PPPD;
- •Pregnant women.
- •Inclusion criteria for the control group:
- •Previous COVID-19 infection (matched for timing to the PPPD-glialia group).
- •Exclusion criteria for the control group:
- •Presence of neurological and otological disorders;
- •Pregnant women.
结局指标
主要结局
Neuroinflammation Assessment
时间窗: T0 (Baseline); T1 (60 days)
The neuroinflammation assessment will evaluate serum neurofilament light chain (NfL) levels as a biomarker for neuroinflammation in participants with PPPD and controls. Blood samples will be collected via venipuncture at the Foundation Santa Lucia IRCCS. The analysis will utilize a sensitive enzyme-linked immunosorbent assay (ELISA) method to quantify NfL levels. The Simoa NF-Light advantage kit will enable accurate detection of low concentrations. This assessment aims to compare neuroinflammation levels at baseline (T0) and after treatment (T1) across the study groups.
次要结局
- Gait Quality Assessment(T0 (Baseline); T1 (60 days))
- Video Head Impulse Test (vHIT)(T0 (Baseline).)
- Dizziness Handicap Inventory (DHI)(T0 (Baseline); T1 (60 days))
- Niigata Questionnaire(T0 (Baseline); T1 (60 days))
- Brain Fog Scale (BFS)(T0 (Baseline); T1 (60 days))
- Personality Traits Assessment (NEO-P-I-3)(T0 (Baseline))