Using Glialia for Treating Persistent Perceptual Postural Dizziness

NCT06741358 | Recruiting Phase 4 DMC

• 1 other identifier: N.153/SL/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Postural Perceptual Dizziness

Keywords

Persistent Perceptual Postural Dizziness; Functional disorder; Neuroinflammation; Human Palmitoylethanolamide (umPEA); Neurofilaments; Balance

Outcome Measures

Primary Outcomes (1)

• Neuroinflammation Assessment

  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.

  T0 (Baseline); T1 (60 days)

Secondary Outcomes (6)

• 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)

Study Arms (3)

Glialia

EXPERIMENTAL

Participants in the PPPD-Glialia group must be between the ages of 18 and 65 years and have a confirmed diagnosis of Persistent Perceptual Postural Dizziness (PPPD). They must also either have recovered from a COVID-19 infection or have no history of such an infection. Individuals with concurrent neurological or otological disorders, as well as pregnant women, will be excluded from this group.

Other: Glialia

Placebo

PLACEBO COMPARATOR

Participants in the PPPD-Glialia group must be between the ages of 18 and 65 years and have a confirmed diagnosis of Persistent Perceptual Postural Dizziness (PPPD). They must also either have recovered from a COVID-19 infection or have no history of such an infection. Individuals with concurrent neurological or otological disorders, as well as pregnant women, will be excluded from this group.

Other: Placebo

Control group

OTHER

The Control Group will consist of individuals aged between 18 and 65 years who have a previous history of COVID-19 infection, matched for timing with the PPPD-Glialia group. Exclusion criteria for this group will also include the presence of any neurological or otological disorders and pregnancy, ensuring that the results are focused on the impact of the Glialia supplement in the context of PPPD and recovery from COVID-19.

Other: Control

Interventions

Glialia OTHER

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.

Glialia

Placebo OTHER

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 quality will be performed.

Placebo

Control OTHER

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 Glialia in the context of both PPPD and recovery from COVID-19.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Diagnosis of PPPD;
• Recovery from COVID-19 infection or absence of previous infection.
• Diagnosis of PPPD;
• Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).

You may not qualify if:

• Presence of concurrent neurological and otological disorders other than PPPD;
• Pregnant women.
• Previous COVID-19 infection (matched for timing to the PPPD-glialia group).
• Presence of neurological and otological disorders;
• Pregnant women.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Fondazione Santa Lucia IRCCS

Rome, RM, 00142, Italy

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iole Indovina, PhD

  Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy ; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.

  PRINCIPAL INVESTIGATOR

• Arianna Di Stadio, PhD

  GF Ingrassia Department, University of Catania, Catania, Italy.

  STUDY DIRECTOR

• Diego Piatti, PT

  Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.

  STUDY CHAIR

• Gianluca Paolocci, PhD

  Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, 98125 Messina, Italy; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.

  STUDY CHAIR

• Gianfranco Bosco, PhD

  Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.

  STUDY CHAIR

• Cinzia Ciccacci, PhD

  Unicamillus, Saint Camillus International University of Medical Sciences.

  STUDY CHAIR

• Marco Tramontano, PhD

  Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater University of Bologna, 40138 Bologna, Italy; Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.

  STUDY CHAIR

• Francesca Giansanti, MSc

  Unicamillus, Saint Camillus International University of Medical Sciences.

  STUDY CHAIR

Central Study Contacts

Iole Indovina, PhD

CONTACT

0039 0651501476; i.indovina@hsantalucia.it

Diego Piatti, PT

CONTACT

0039 0651501479; d.piatti@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: December 21, 2024
• Primary Completion: October 10, 2025
• Study Completion (Estimated): October 10, 2026
• Last Updated: November 20, 2025

Record last verified: 2024-11

Locations

IT (1)