Scans the neck's superior cervical ganglion in people with Parkinson's disease
Tests a PET neck scan in adults with Parkinson disease to study the ganglion.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Rome, ItalySee the site
- Trial code
- Registry title
- Superior Cervical Ganglion in Parkinson's Disease
- Status
- Recruiting
- People taking part
- 18 people, planned
- Started
- 1 Jan 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- PET-Neck Parkinsonian patients
- Record updated
- 1 March 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 30 to 80 with Parkinson's disease, diagnosed by the Movement Disorder Society criteria. It studies a nerve cluster in the neck using a PET-CT scan.
- Age
- 30 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Parkinson's disease diagnosed by the criteria of the Movement Disorder Society. The record gives no stage.
- Earlier treatment
- People cannot join if they took a dopamine blocker or dopamine-reducing drug at a dose and time that fit drug-induced parkinsonism.
- Biomarker or test result
- People cannot join if functional brain imaging of the dopamine system is normal.
Main reasons for not taking part
- Clear signs of cerebellar problems, such as unsteady walking or limb ataxia
- Palsy of downward gaze or slowing of downward eye movements
- Probable frontotemporal dementia or primary progressive aphasia within the first 5 years of the disease
- Parkinson signs only in the legs for more than 3 years
- No visible response to high-dose levodopa despite at least moderate disease
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society
Who cannot take part
- Treatment with a dopamine receptor blocker or dopamine-reducing agent at a dose and time consistent with drug-induced parkinsonism
- Diagnosis of probable behavioral variant of frontotemporal dementia or primary progressive aphasia, defined according to consensus criteria, within the first 5 years of the disease
- Absence of observable response to high-dose levodopa despite at least moderate disease severity
- Documentation of an alternative condition known to induce parkinsonism and plausibly related to the patient's symptoms, or, expert medical opinion that, based on the full diagnostic evaluation, believes that an alternative syndrome is more likely than Parkinson Disease
- Unambiguous cerebellar abnormalities, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (eg, sustained gaze-evoked nystagmus, square wave macro jerks, hypermetric saccades)
- Palsy of vertical descending supranuclear gaze or selective slowing of vertical descending saccades
- Parkinsonian features limited to the lower limbs for more than 3 years
- Unequivocal cortical sensory deficit (i.e., graphesthesia, stereognosis with intact primary sensitivities), clear ideomotor apraxia of limbs, or progressive aphasia
- Normal functional neuroimaging of the presynaptic dopaminergic system
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyContact: Liverana Lauretti, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- PET-Neck Parkinsonian patientsTreatment being tested
Brain and neck PET-CT with 68Ga-PSMA scan would be administered
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Peripheral Catecholaminergic System in Neurodegenerative Diseases of the Central Nervous System. A Pilot Study.
- Plain-language title
- Scans the neck's superior cervical ganglion in people with Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05741151, who can take part
- Record updated
- 1 March 2023