Actively Recruiting
Superior Cervical Ganglion in Parkinson's Disease
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-03-01
18
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In several neurodegenerative diseases, such as Parkinson's disease, the progressive loss of neurons of monoaminergic systems leads to the development of characteristic clinical manifestations. Therefore, since the discovery that neurodegenerative phenomena are the basis of these Central Nervous System (CNS) diseases, re-innervation strategies have been studied that would allow to stop or at least slow down neurodegenerative phenomena, restoring lost catecholaminergic transmission. Cell therapy in Parkinson's disease aims to treat motor disorders, but should not affect cognitive disorders that result from pathological alterations external to CNS and affecting other transmission systems, such as noradrenergic and cholinergic. These limitations lead to the search for new approaches based on the use of different cell types, but currently these scenarios still seem far away. The theme of cerebral re-innervation in the treatment of neurodegenerative diseases is at the center of numerous translational and clinical research studies, developed according to various approaches and models, which testify to all the complexity and charm of the subject. Among the possible sources for a catecholamine reinnervation in Parkinson's disease, Superior Cervical Ganglion (SCG) could represent a valid autologous source: however, there is no functional evaluation in the literature that expresses the involvement or not of the ganglion in the neurodegenerative process. This clinical study project is the first and essential phase of a larger project aimed at verifying the possibility of autologous catecholamine reinnervation in degenerative diseases of the CNS using the peripheral catecholamine system and in particular the superior cervical ganglion (GCS). The aim of this project is to evaluate whether the peripheral catecholaminergic system, and in particular the SCG, is involved in the process of neurodegeneration. For this purpose, for an "in vivo" functional study, the suitability of the PET-CT 68Ga-PSMA examination will be studied in particular.
CONDITIONS
Official Title
Superior Cervical Ganglion in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society
You will not qualify if you...
- Unambiguous cerebellar abnormalities such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities
- Palsy of vertical descending supranuclear gaze or selective slowing of vertical descending saccades
- Diagnosis of probable behavioral variant of frontotemporal dementia or primary progressive aphasia within the first 5 years of the disease
- Parkinsonian features limited to the lower limbs for more than 3 years
- Treatment with a dopamine receptor blocker or dopamine-reducing agent at a dose and time consistent with drug-induced parkinsonism
- Absence of observable response to high-dose levodopa despite at least moderate disease severity
- Unequivocal cortical sensory deficit, clear ideomotor apraxia of limbs, or progressive aphasia
- Normal functional neuroimaging of the presynaptic dopaminergic system
- Documentation of an alternative condition known to induce parkinsonism or expert medical opinion favoring an alternative syndrome over Parkinson Disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
L
Liverana Lauretti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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