Exploring the Role of the Superior Cervical Ganglion in Parkinson's Disease
Evaluation of Peripheral Catecholaminergic System in Neurodegenerative Diseases of the Central Nervous System. A Pilot Study.
This study is testing a new treatment that aims to help people with Parkinson's disease by targeting a specific nerve group to see if it can improve their symptoms without affecting their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05741151 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential of re-innervation strategies targeting the superior cervical ganglion to address neurodegenerative phenomena in Parkinson's disease. A multidisciplinary team will evaluate eligible patients through neurological assessments and imaging techniques to ensure accurate diagnosis and staging of the disease. The study aims to explore cell therapy approaches that could restore catecholaminergic transmission without affecting cognitive functions. Participants will undergo a series of evaluations to determine their eligibility and monitor their condition throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's disease according to the Movement Disorder Society criteria.
Not a fit: Patients with significant cerebellar abnormalities or those with Parkinsonian features limited to the lower limbs for an extended period may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function in patients with Parkinson's disease.
How similar studies have performed: While the exploration of neuroregeneration in Parkinson's disease is ongoing, this specific approach targeting the superior cervical ganglion is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society Exclusion Criteria: * 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
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Liverana Lauretti, MD
- Email: Liverana.Lauretti@policlinicogemelli.it
- Phone: +39 06 3015 5031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.