Using Glialia for Treating Persistent Perceptual Postural Dizziness

Official title

Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance: A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial

Overview

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.

Interventions

• Other Glialia
  Participants in the PPPD-Glialia group will receive the Glialia supplement, which contains 700 mg of Palmitoylethanolamide (umPEA) along with 70 mg of additional supportive ingredients. Each participant will be instructed to take two soluble sachets daily for a total duration of 60 days. This group aims to evaluate the effects of Glialia on PPPD, with outcomes assessed for neuroinflammation, mental clarity, quality of life, balance, and gait quality.
• Other Placebo
  Participants assigned to the PPPD-Placebo group will receive a placebo that is designed to be indistinguishable from the Glialia supplement in terms of appearance and packaging. They will also take two soluble sachets daily for 60 days. The purpose of this group is to serve as a control to evaluate the effects of the Glialia supplement by comparing the outcomes with those of the PPPD-Glialia group. The same assessments for neuroinflammation, mental clarity, quality of life, balance, and gait qua
• Other Control
  Individuals in the Control Group will receive the same Glialia supplement as the PPPD-Glialia group, containing 700 mg of Palmitoylethanolamide (umPEA) and 70 mg of supportive ingredients. They will also take two soluble sachets daily for 60 days. The primary goal for this group is to assess how the Glialia supplement affects neuroinflammation and related outcomes in individuals who have recovered from COVID-19 but do not have PPPD. This comparison will help clarify the potential effects of Glia

Primary outcome measures

• Neuroinflammation Assessment [Time frame: T0 (Baseline); T1 (60 days)]

Secondary outcome measures (6)

• Gait Quality Assessment [Time frame: T0 (Baseline); T1 (60 days)]
• Video Head Impulse Test (vHIT) [Time frame: T0 (Baseline).]
• Dizziness Handicap Inventory (DHI) [Time frame: T0 (Baseline); T1 (60 days)]
• Niigata Questionnaire [Time frame: T0 (Baseline); T1 (60 days)]
• Brain Fog Scale (BFS) [Time frame: T0 (Baseline); T1 (60 days)]
• Personality Traits Assessment (NEO-P-I-3) [Time frame: T0 (Baseline)]

Eligibility criteria

Inclusion criteria 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).

Exclusion criteria 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Fondazione Santa Lucia IRCCS — Rome

Publications

• Tramontano M, Casagrande Conti L, Orejel Bustos AS, Ferri N, Lelli T, Nocentini U, Grasso MG, Turolla A, Pillastrini P, Manzari L. Abnormal Vestibulo-Ocular Reflex Function Correlates with Balance and Gait Impairment in People with Multiple Sclerosis. Audiol Res. 2024 Sep 9;14(5):799-808. doi: 10.3390/audiolres14050067. PMID 39311220
• Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011. PMID 2317323
• Castillejos-Carrasco-Munoz R, Peinado-Rubia AB, Lerida-Ortega MA, Ibanez-Vera AJ, Tapia-Toca MC, Lomas-Vega R. Validity and reliability of the Niigata PPPD Questionnaire in a Western population. Eur Arch Otorhinolaryngol. 2023 Dec;280(12):5267-5276. doi: 10.1007/s00405-023-08038-1. Epub 2023 Jun 2. PMID 37266755
• Indovina I, Riccelli R, Staab JP, Lacquaniti F, Passamonti L. Personality traits modulate subcortical and cortical vestibular and anxiety responses to sound-evoked otolithic receptor stimulation. J Psychosom Res. 2014 Nov;77(5):391-400. doi: 10.1016/j.jpsychores.2014.09.005. Epub 2014 Sep 16. PMID 25262497

Identifiers

NCT: NCT06741358 · N.153/SL/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗