Prospective Study of Autonomic and Motor Disorders in Neurodegenerative Diseases

JRCT ID: jRCT1030230155

Registered date:21/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spinocerebellar degeneration, multiple system atrophy, Parkinson's disease
• Date of first enrollment: 13/09/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Heart rate variability and heart rate turbulence by 24-hour Holter electrocardiography
The data is recorded by "Long-time ECG recorder RAC-5103" manufactured by Nihon Kohden, and analyzed by "Analysis Center Network Holter" manufactured by Nihon Kohden.

RR interval test by ECG examination
The ECG-2500 series (model: ECG-2550) or ECG-2400 series (model: ECG-2450) electrocardiographs manufactured by Nihon Kohden will be used for measurement.

Simple residual urine volume measurement using a bladder ultrasound diagnostic imaging device (Lilliam IP200)
The Lilliam IP200 (medical device certification number 227ADBZX00146A01) used in this study is a device that can measure the amount of urine in the bladder using ultrasound and can easily measure the amount of residual urine.

Outcome(s)

Primary Outcome

Evaluation of heart rate variability/heart rate disturbance by 24-hour Holter ECG
Measurement of residual urine volume
Gait analysis

Secondary Outcome

CV-RR by RR interval ECG
Questionnaire on urination
Blood tests
Cognitive function tests (MMSE, FAB, MOCA-J)
Shellong test
Head MRI
SARA, ICARS, UMSARS, UPDRS, PSPRS-J, ALSFRS-R, Limb Norris scale, Norris Bulbar scale

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients 18 years of age or older, regardless of gender.
(2) Patients who meet one of the following criteria are eligible
1. patients with spinocerebellar degeneration who meet the diagnostic criteria of Definite or Probable according to the Intractable Disease Information Center of the Ministry of Health, Labour and Welfare of Japan
2. patients with multiple system atrophy who meet the diagnostic criteria according to the 2nd Consensus Criteria (2008)
3. patients with Parkinson's disease who meet the diagnostic criteria of the Intractable Disease Information Center of the Ministry of Health, Labour and Welfare
4. patients with progressive supranuclear palsy who meet the diagnostic criteria of the Intractable Disease Information Center of the Ministry of Health, Labour and Welfare
Patients with basal ganglia degeneration who meet the diagnostic criteria of the Intractable Disease Information Center of the Ministry of Health, Labour and Welfare (MHLW)
6. patients with amyotrophic lateral sclerosis who meet the criteria for clinically probable-laboratory-supported ALS or higher on the El Escorial revised Airlie House diagnostic criteria
7. patients with neuronal inclusion body disease who meet the diagnostic criteria proposed by Chen et al. in 2020
8. patients with diseases other than 1-7 who are hospitalized in the Department of Neurology of the hospital
3) Patients without indwelling urinary catheter
4) Patients who can walk longer than 10 m with firm assistance when gait analysis is performed.
5) Patients who have given written consent to participate in this study.

Exclude criteria

(1) Patients with a history of intracranial or spinal cord diseases other than the target diseases
(2) Patients with atrial fibrillation
(3) Other patients who are judged by the physician to be ineligible

Related Information

• Primary Sponsor: Ikeda Yoshio