Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062990) titled 'A Study of the Relationship Between Brain MRI Findings and Nuclear Medicine Test Results in Parkinsonian Syndromes' on Sept. 26.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Parkinsonian Syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the relationship between imaging information derived from brain MRI and nuclear medicine imaging indices associated with parkinsonian syndromes, and to explore the potential of novel MRI-based imaging analysis methods. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with Parkinson disease (PD), dementia with Lewy bodies (DLB), essential tremor (ET), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), or isolated REM sleep behavior disorder (iRBD), as well as individuals who were initially suspected of having parkinsonian syndrome (PS), including PD, but had a normal DaTscan result, will be eligible if they attended the Department of Neurology, Juntendo University Hospital, between January 1, 2010 and the date of study approval and underwent both brain MRI and DaTscan examinations.

Inclusion Criteria

1. DaTscan must have been performed within 12 months before or after the brain MRI examination.

2. Participants must have a clinical diagnosis of PD, DLB, ET, PSP, MSA, or iRBD, or must have been initially suspected of having PS, including PD, but subsequently had a normal DaTscan result.

Reference Diagnostic Criteria

PD: Clinically established PD or clinically probable PD according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson Disease.

DLB: Probable or possible DLB according to the Fourth Consensus Report of the DLB Consortium (McKeith et al., 2017).

PSP: Probable or possible PSP according to the 2017 MDS Diagnostic Criteria for PSP.

MSA: Clinically established MSA or clinically probable MSA according to the 2022 MDS Diagnostic Criteria for MSA.

iRBD: REM sleep behavior disorder meeting the 2023 AASM ICSD-3-TR diagnostic criteria for RBD, without secondary causes or manifest neurological disease.

The group with normal DaTscan results may include healthy individuals and patients with drug-induced parkinsonism (DIP), vascular parkinsonism (VaP), idiopathic normal pressure hydrocephalus (iNPH), and other conditions. Key exclusion criteria - Exclusion Criteria 1. Patients with a history of head trauma, metabolic disease, severe psychiatric illness, or other central nervous system disorders. 2. Patients taking any of the following medications: sertraline, reserpine, amphetamines, methamphetamine, cocaine, methylphenidate, bupropion, mazindol, phentermine, benztropine, modafinil, or tetrabenazine. 3. Patients who are deemed inappropriate for participation in the study by the principal investigator. Target Size - 1940

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 06 Day Date of IRB - 2026 Year 05 Month 30 Day Anticipated trial start date - 2026 Year 05 Month 30 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072102

Disclaimer: Curated by HT Syndication.