Using Glialia for Treating Persistent Perceptual Postural Dizziness (GLI-PPPD)

November 17, 2025 updated by: I.R.C.C.S. Fondazione Santa Lucia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00142
        • Recruiting
        • Fondazione Santa Lucia IRCCS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Iole Indovina, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glialia
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
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.
Placebo Comparator: Placebo
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
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.
Other: Control group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuroinflammation Assessment
Time Frame: 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.
T0 (Baseline); T1 (60 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait Quality Assessment
Time Frame: T0 (Baseline); T1 (60 days)
Gait quality will be assessed using inertial sensors. Set of magneto-inertial sensors (Opal, APDM Inc., Portland, Oregon, USA) will be used during the execution of walking motor tasks. Changes of continuous accelerometer signals will be recorded.
T0 (Baseline); T1 (60 days)
Video Head Impulse Test (vHIT)
Time Frame: T0 (Baseline).
The Video Head Impulse Test (vHIT) is performed to assess the vestibulo-ocular reflex (VOR). Conducted before T0, this test ensures that participants do not have underlying VOR dysfunction prior to inclusion in the study.
T0 (Baseline).
Dizziness Handicap Inventory (DHI)
Time Frame: T0 (Baseline); T1 (60 days)
The Dizziness Handicap Inventory (DHI) measures the impact of dizziness on an individual's daily life and activities. Participants will complete this questionnaire at T0 and T1 to assess any changes in disability related to dizziness. The DHI provides insights into the physical, emotional, and functional limitations experienced by patients, facilitating a comprehensive evaluation of the treatment's effectiveness in improving quality of life. The maximum score for the DHI ranges from 0 to 100, with higher scores indicating greater instability.
T0 (Baseline); T1 (60 days)
Niigata Questionnaire
Time Frame: T0 (Baseline); T1 (60 days)
The Niigata questionnaire assesses subjective symptoms related to PPPD. It is administered to participants at both T0 and T1 to evaluate changes in symptom perception over the treatment period. The questionnaire consists of various items that help quantify the intensity and frequency of PPPD symptoms, allowing for a comparative analysis of symptom improvement in the PPPD-glialia and PPPD-placebo groups. The maximum score is 72, with higher scores reflecting greater instability. Each of its three domains (upright posture/walking, movement, and visual stimulation) has a maximum score of 24.
T0 (Baseline); T1 (60 days)
Brain Fog Scale (BFS)
Time Frame: T0 (Baseline); T1 (60 days)
The Brain Fog Scale (BFS) is designed to evaluate cognitive clarity and mental processing in participants. Administered at both T0 and T1, this scale focuses on self-reported cognitive difficulties, such as concentration, memory, and mental fatigue. Changes in BFS scores will help determine the cognitive effects of the treatment, particularly in the context of PPPD-related cognitive symptoms.
T0 (Baseline); T1 (60 days)
Personality Traits Assessment (NEO-P-I-3)
Time Frame: T0 (Baseline)
The NEO-P-I-3 questionnaire will be administered at T0 to evaluate personality traits, particularly focusing on neuroticism, which is relevant for understanding the psychological aspects of PPPD. This assessment will provide baseline data on individual personality profiles and allow for exploration of potential correlations between personality traits and treatment outcomes in PPPD patients. A statistical analysis will be conducted to evaluate specific areas of personality traits.
T0 (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.R.C.C.S. Fondazione Santa Lucia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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.
  • Study Director: Arianna Di Stadio, PhD, GF Ingrassia Department, University of Catania, Catania, Italy.
  • Study Chair: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N.153/SL/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings