NCT05741151Recruiting
Superior Cervical Ganglion in Parkinson's Disease
Evaluation of Peripheral Catecholaminergic System in Neurodegenerative Diseases of the Central Nervous System. A Pilot Study.
Source: ClinicalTrials.gov · Last updated 1 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 14 Feb 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Parkinson disease
- NCT number
- NCT05741151
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with a dopamine receptor blocker or dopamine-reducing agent at a dose and time consistent with drug-induced parkinsonism
Other illness
- 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
Other
- 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
Who the study is looking for
- Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.