Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies

Who is this study for? Adults with suspected encephalopathy
What treatments are being studied? Nasal Brushing
Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous etiology. Several causes have been recognized including neurodegenerative, vascular, infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders. While 30-50% of acute encephalitis remains without etiological definition, definitive criteria for neurodegenerative diseases are usually unavailable in vivo and possible or probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa that carries the specialized sensory organ for the modality of smell; the olfactory epithelium is composed of five principal cell types including olfactory receptor neurons. A sample of OM may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients, not-contraindicated in patients with raised intracranial pressure and associated with almost no side-effects. Nasal brushing has recently been proposed for the in vivo diagnosis of Creutzfeldt-Jakob disease (CJD). Aims of the project are: 1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU) specialists in the technique of nasal brushing; 2. Conducting a prospective study comparing the use of nasal brushing with gold-standard criteria in the diagnosis of Encephalopathies; 3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies. A prospective, case control, multicentric study enrolling 400 patients and 100 controls (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be diagnosed and followed according to international guidelines and local clinical practice. Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the diagnosis according to the clinical or radiological suspect.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• age\>18 years;

• signing a written informed consent (by the patients or his/her legal representant);

• clinical suspect of encephalopathy (acute or subacute) including acute encephalitis, neurodegenerative disorders and HIV-associated neurocognitive disorders.

• age\>18 years;

• signing a written informed consent (by the patients or his/her legal representant); • clinical indication for rhinoscopy for stenotic disease of nasal sept or turbinates.

Locations
Other Locations
Italy
University of Torino
RECRUITING
Torino
Contact Information
Primary
ANDREA CALCAGNO, MD, DTM&H
andrea.calcagno@unito.it
+390114393884
Time Frame
Start Date: 2016-03
Completion Date: 2023-02
Participants
Target number of participants: 250
Treatments
Experimental: Brushing
Patients will undergo nasal brushing as further described additionally to other gold standard practices according to the suspected aetiology (brain MRI, lumbar puncture, plasma tests, etc.)
Sponsors
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov