Superior Cervical Ganglion in Parkinson's Disease

NCT05741151 | Recruiting

• 1 other identifier: 4656
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parkinson Disease

Keywords

Superior Cervical Ganglion; Catecholaminergic system; Neurodegeneration; Neuroregeneration

Outcome Measures

Primary Outcomes (1)

• Capacity of the Superior Cervical Ganglion in parkinsonian patients

  The capacity of the Ganglion would be assessed through the analysis of degree of captation (68Ga-CTPET)

  through study completion, an average of 3 years

Study Arms (1)

PET-Neck Parkinsonian patients

EXPERIMENTAL

Brain and neck PET-CT with 68Ga-PSMA scan would be administered

Diagnostic Test: PET-Neck Parkinsonian patients

Interventions

PET-Neck Parkinsonian patients DIAGNOSTIC_TEST

Brain and neck PET-CT scan with 68Ga-PSMA to detect metabolism in the Superior Cervical Ganglion of both sides.

PET-Neck Parkinsonian patients

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society

You may not qualify if:

• 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
• 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
• 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 (i.e., graphesthesia, stereognosis with intact primary sensitivities), 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 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (1)

• Bialek EJ, Malkowski B. Are superior cervical sympathetic ganglia avid on whole body 68Ga-PSMA-11 PET/magnetic resonance?: a comprehensive morphologic and molecular assessment in patients with prostate cancer. Nucl Med Commun. 2019 Nov;40(11):1105-1111. doi: 10.1097/MNM.0000000000001083.

  PMID: 31469805 RESULT

MeSH Terms

Conditions

Parkinson Disease; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liverana Lauretti, MD

CONTACT

+39 06 3015 5031; Liverana.Lauretti@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

IT (1)