Persistent Postural Perceptual DizzinessPhase 4GLI-PPPDNCT06741358
Using Glialia for Treating Persistent Perceptual Postural Dizziness
A Phase 4 study testing Glialia in people with Persistent Postural Perceptual Dizziness, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Postural Perceptual Dizziness
- What is being tested?
- Glialia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2024to 10 May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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).
- -Previous COVID-19 infection (matched for timing to the PPPD-glialia group).
Who cannot join
- Presence of concurrent neurological and otological disorders other than PPPD;
- Pregnant women.
- Presence of neurological and otological disorders;
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Santa Lucia IRCCS
Rome, RM, 00142
Diego Piatti, PT, 0039 0651501479, d.piatti@hsantalucia.it
Iole Indovina, PhD, 0039 0651501476, i.indovina@hsantalucia.it
About this study
Official title: 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.
- Conditions
- Persistent Postural Perceptual Dizziness
- Being tested
- Glialia, Placebo, Control
- Keywords
- Persistent Perceptual Postural Dizziness, Functional disorder, Neuroinflammation, Human Palmitoylethanolamide (umPEA), Neurofilaments, Balance
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlialiaOther
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.
PlaceboOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 (Baseline); T1 (60 days)
Secondary outcomes (6)
Gait Quality Assessment
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.
Measured: T0 (Baseline); T1 (60 days)
Video Head Impulse Test (vHIT)
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.
Measured: T0 (Baseline).
Dizziness Handicap Inventory (DHI)
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.
Measured: T0 (Baseline); T1 (60 days)
Niigata Questionnaire
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.
Measured: T0 (Baseline); T1 (60 days)
Brain Fog Scale (BFS)
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.
Measured: T0 (Baseline); T1 (60 days)
Personality Traits Assessment (NEO-P-I-3)
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.
Measured: T0 (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start21 Dec 2024
- Primary completion10 Oct 2025
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Persistent Postural Perceptual DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iole Indovina, PhD, Principal investigator, 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.Arianna Di Stadio, PhD, Study director, GF Ingrassia Department, University of Catania, Catania, Italy.Diego Piatti, PT, Study chair, Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.Gianluca Paolocci, PhD, Study chair, 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.Gianfranco Bosco, PhD, Study chair, 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.Cinzia Ciccacci, PhD, Study chair, Unicamillus, Saint Camillus International University of Medical Sciences.Marco Tramontano, PhD, Study chair, 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.Francesca Giansanti, MSc, Study chair, Unicamillus, Saint Camillus International University of Medical Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741358
- Sponsor's protocol ID
- N.153/SL/24
- Acronym
- GLI-PPPD
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39311220Jacobson 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.
PubMed 2317323Castillejos-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.
PubMed 37266755Indovina 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.
PubMed 25262497