Clinical trial NCT06741358: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Persistent Postural Perceptual Dizziness
Keywords: Persistent Perceptual Postural Dizziness
Functional disorder
Neuroinflammation
Human Palmitoylethanolamide (umPEA)
Neurofilaments
Balance
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Neuroinflammation Assessment
timeFrame: T0 (Baseline); T1 (60 days)
Secondary outcomes:
measure: Gait Quality Assessment
timeFrame: T0 (Baseline); T1 (60 days)
measure: Video Head Impulse Test (vHIT)
timeFrame: T0 (Baseline).
measure: Dizziness Handicap Inventory (DHI)
timeFrame: T0 (Baseline); T1 (60 days)
measure: Niigata Questionnaire
timeFrame: T0 (Baseline); T1 (60 days)
measure: Brain Fog Scale (BFS)
timeFrame: T0 (Baseline); T1 (60 days)
measure: Personality Traits Assessment (NEO-P-I-3)
timeFrame: T0 (Baseline)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Santa Lucia IRCCS
state: RM
Study officials:
affiliation: 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.
name: Iole Indovina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: GF Ingrassia Department, University of Catania, Catania, Italy.
name: Arianna Di Stadio, PhD
role: STUDY_DIRECTOR
affiliation: Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation, 00179 Rome, Italy.
name: Diego Piatti, PT
role: STUDY_CHAIR
affiliation: 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.
name: Gianluca Paolocci, PhD
role: STUDY_CHAIR
affiliation: 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.
name: Gianfranco Bosco, PhD
role: STUDY_CHAIR
affiliation: Unicamillus, Saint Camillus International University of Medical Sciences.
name: Cinzia Ciccacci, PhD
role: STUDY_CHAIR
affiliation: 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.
name: Marco Tramontano, PhD
role: STUDY_CHAIR
affiliation: Unicamillus, Saint Camillus International University of Medical Sciences.
name: Francesca Giansanti, MSc
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.