Normal adult cerebral perfusion neuroimage study

JRCT ID: jRCTs031230230

Registered date:14/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 14/07/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 45 minutes continuous scan followed by 111MBq bolus injection of 123I-IMP.

Outcome(s)

• Primary Outcome: History taking and neurological assessment in 40 healthy individuals and calculates average cerebral blood flow of whole brain.

Secondary Outcome

1) Total MMSE score 24 or above are required.
2) ACEIII (Addenbrooke's Cognitive Examination Cognitive III) screening tests, consist of five cognitive domain (attention, memory, fuency, language, visuospatial). Total test time : 15 to 20 mins.
3) MoCA-J (Japanese version of Montreal Cognitive Cognitive Assessment) Screening testformild cognitive impairment. Total test time : 10 mins.
4) Japanese version of 4 A's test (4AT) is a screening test for delirium. Total test time 1 to 2 mins.
5) AQ-J (Japanese version of Autism spectrum Quotient) Assessment test for autism spectrum disorder. Total test time :10 mins.
6) BIS11(Barratt Impulsiveness Scale)Assessment test for impusiveness. Total test time : 10 mins.
7) BIS/BAS(Japanese version of ehavioral Inhibition System/Behavioral Activation System scale)Assessment tool for behavior inhibition system and behavior activation system. Total test time : 15 mins.
8) FAB(Frontal assessment battery)Screening test for frontal function. Total test time : 5 mins.
9) FOG-Q(Freezing of Gait questionnaire)Assessment test for gait freezing. Total test time:1 to 2 mins.
10) SED-11Q(Symptoms of Early Dementia 11 Questionnaire)Questionnaire for screening dementia and awareness of having dementia. Total test time:5 mins.
11) Forgiveness scale: Assessment tool for tendency to foregive. Total test time : 15 mins.
12) SF-MPQ(Short Form McGill Pain Questionnaire)Self rating scale for pain. Total test time : 5 mins
13) Noise pareidoria test: Screening and assessment tool for visual hallucination. Total test time : 5 mins.
14) Overactive Bladder Symptom Score: OABSS. Self reported questionnaire for urinary symptoms. Total test time:5 mins.
15) Parkinson's disease sleep scale 2:PDSS 2. Self reported questionnaire for sleping condition for the past 7 days. Total test time:5 mins
16) Evoked electroencephalogram (EEG).Simplifed EEG system built in a headphone, evoked by visual and auditory stimulation. P300 wave will be calculated and variability is assessed. Total test time :15 mins.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Those who meet all the following conditions are eligible.
1) Age at consent between 20 to 85.
2) Person who are capable of conducting studies within required period.
3) Subjects who have no problem if neuropsychological examination is performed within 3 months before obtaining informed consent
4) Subjects who are age-appropriate and have no problems if a head MRI scan has been performed within 3 months before obtaining informed consent
5) Subjects who have no problem in neuropsychological examination in the screening test after obtaining informed consent
6)Subjects who have age-appropriate brain MRI images and no problems in the screening test after obtaining informed consent
7)Person who are capable of providing written consent

Exclude criteria

Those who meet any of the following conditions are not eligible.
1) Those who are pregnant, or possible pregnancy, or breastfeeding.
2) Those with prior neurological or psychiatric disorders which could interfere with cognitive function.
3) Those with severe physical problem (e.g. in liver, kidney, or endocrine system).
4) Those having prior serious head trauma.
5) Those who are unable to perform MRI (i.e. metallic implants, claustrophobia, tatoos).
6) Those who have impared cognitive function.
7) Those who are incapable of completing the study, judged by the physician.

Related Information

• Primary Sponsor: Hirano Shigeki
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital),Japan Agency for Medical Research and Development