Persistent Postural Perceptual Dizziness
Conditions
Keywords
Persistent Perceptual Postural Dizziness, Functional disorder, Neuroinflammation, Human Palmitoylethanolamide (umPEA), Neurofilaments, Balance
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.
Interventions
OTHERGlialia
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.
OTHERPlacebo
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.
OTHERControl
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.
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuroinflammation Assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Video Head Impulse Test (vHIT) | 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. |
| Dizziness Handicap Inventory (DHI) | 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. |
| Gait Quality Assessment | 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. |
| Brain Fog Scale (BFS) | 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. |
| Personality Traits Assessment (NEO-P-I-3) | 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. |
| Niigata Questionnaire | 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. |
Countries
Italy
Contacts
Primary ContactIole Indovina, PhD
Backup ContactDiego Piatti, PT
Outcome results
None listed