Tokyo, Oct. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059546) titled 'Longitudinal Study of Central Nervous System Function in Myotonic Dystrophy' on Oct. 27.
Study Type:
Observational
Primary Sponsor:
Institute - NHO Osaka Toneyama Medical Center
Condition:
Condition - Myotonic Dystrophy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the longitudinal changes in cognitive function in patients with myotonic dystrophy after 10 years from the baseline.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - This study will include patients aged 18 years or older with confirmed diagnosis of DM1.
Patients must meet all of the following criteria:
1) Patients diagnosed with DM1 based on genetic testing or clinical symptoms and family history
2) Patients who participated in a previous longitudinal study and have available information regarding cognitive assessment
Key exclusion criteria - Patients with congenital conditions, severe symptoms, severe visual impairment, severe hearing impairment, or other factors making research participation difficult will be excluded.
Patients meeting any of the following criteria will not be enrolled in this study:
1) Congenital DM1
2) Severe symptoms, visual impairment, or hearing impairment making research participation difficult
3) If the principal investigator or co-investigator determines the patient is not suitable for participation in this study
Target Size - 67
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 27 Day
Date of IRB - 2025 Year 09 Month 08 Day
Anticipated trial start date - 2025 Year 10 Month 09 Day
Last follow-up date - 2027 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068113
Disclaimer: Curated by HT Syndication.
