TSPO PET in the Evaluation of Neuroinflammation in Patients with Multiple System Atrophy

NCT06890390 | Recruiting

• 1 other identifier: Rapid24280
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to apply PET/MR techniques targeting TSPO to explore the temporal and spatial alterations characterizing neuroinflammation in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis of MSA disease.

Conditions

Multiple System Atrophy - Cerebellar Subtype (MSA-C); Multiple System Atrophy - Parkinsonian Subtype (MSA-P)

Keywords

Multiple System Atrophy; PETCT; TSPO

Outcome Measures

Primary Outcomes (1)

• Standard uptake value ratio(SUVR)

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (7)

• UMSARS

  From enrollment to the end of treatment at 4 weeks

• H-Y stage

  From enrollment to the end of treatment at 4 weeks

• SCOPA-AUT

  From enrollment to the end of treatment at 4 weeks

• Wexner score

  From enrollment to the end of treatment at 4 weeks

• Frontal Assessment Battery

  From enrollment to the end of treatment at 4 weeks

Study Arms (3)

MSA-C group

Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria，and have symptoms of MSA-C type (with cerebellar ataxia as the main manifestation) mainly include progressive cerebellar ataxia and autonomic dysfunction.

MSA-P group

Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria，and have symptoms of MSA-P (multiple system atrophy-P type) mainly include autonomic dysfunction, Parkinson's syndrome and cerebellar ataxia.

healthy control group

The healthy person who age, gender and other basic conditions matched with the MSA cohort population，and voluntarily participate in this study and sign the informed consent.

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment

You may qualify if:

• Age\> 35 years old, gender is not limited;
• Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
• all patients had been ruled out of polyQ disease by genetic testing;
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• pregnancy or breastfeeding;
• contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
• previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
• History of alcohol or drug abuse

Sponsors & Collaborators

• Min Zhao,MD: lead

Study Sites (1)

Third Xiangya Hospital of Central South University

Hunan, Changsha, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

He RQ 何

CONTACT

0086 186 2214 8869; hrq1234562001@163.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 24, 2025
• Study Start: September 14, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)