Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059099) titled 'Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments' on Sept. 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - patients receiving rehabilitation treatments Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This research project has two objectives. One objective is to investigate (1) the prevalence of olfactory impairments in patients receiving rehabilitation treatments, (2) associations between olfactory impairments and cognitive/motor impairments and outcomes, and (3) their underlying neural mechanisms. The other objective is to elucidate general/inherent associations between olfactory functions and cognitive/motor functions, in particular those relevant to rehabilitation such as memory, learning, and emotion, through behavioral experiments. Basic objectives2 - Others

Intervention: Interventions/Control_1 - behavioral assessments on olfactory, motor, and/or cognitive functions, brain imaging, regular clinical physical/functional evaluations

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - patients a) inpatients/outpatients of the rehabilitation department at Fujita Health University Hospital b) being able to maintain sitting posture on a chair with a backrest c) a current diagnosis or a history of an olfactory, motor or cognitive impairment d) an adult (18 years or older) who can provide informed consent by oneself.

healthy individuals a) no history of brain, neuromuscular, or psychological diseases and no history of epileptic seizure b) an adult (18 years or older) who can provide informed consent by oneself. Key exclusion criteria - patients A) unable to maintain sitting posture on a chair with a backrest B) unable to follow instructions by physicians, therapists, or other health practitioners C) a history of epileptic seizure D) currently pregnant E1) (only for those who receive MRI scanning) having in the body a pacemaker, aneurysm clip, pump, electrodes, or any other metal object that may be incompatible with MRI. E2) (only for those who receive MRI scanning) unable to maintain supine posture during MRI scanning

healthy individuals A) a history of a brain, neuromuscular, or psychological disease or a history of epileptic seizure B) currently pregnant C1) (only for those who receive MRI scanning) having in the body a pacemaker, aneurysm clip, pump, electrodes, or any other metal object that may be incompatible with MRI. C2) (only for those who receive MRI scanning) having non-removable makeup/tattoo/accessory that either (a) is too close to the head/neck, (b) contains MRI-incompatible metals, (c) is so wide/large that it may compromise safety during MRI scanning Target Size - 600

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 07 Month 31 Day Date of IRB - 2025 Year 07 Month 31 Day Anticipated trial start date - 2025 Year 09 Month 22 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067567

Disclaimer: Curated by HT Syndication.