Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT06606418
Eligibility Criteria:
Inclusion Criteria:
* (1) Patients who meet the diagnostic criteria of ICSD-3. To confirm this diagnosis, one of the following conditions must be met: ① The diagnosis is RBD after previous vPSG examination. ② Those who have not been diagnosed should fill in RBDQ-HK. If the score is greater than 20, it indicates possible RBD, and accept vPSG test to confirm the diagnosis.
* (2)Patients belong to iRBD or secondary to the following three alpha-synuclein diseases: Parkinson\'s disease/multiple system atrophy/Lewy body dementia;
* (3) ≥18 years of age, male or female;
* (4) At least 2 episodes of RBD events in the past 2 weeks (recalled by the patient or described by family members), including: ① verbal behavior, such as Shouting and swearing; ② Physical movement behavior, such as waving arms, punching and kicking; ③Falling out of bed, dropping things around you, injuring yourself or others, which is speculated to be related to dreaming behavior;
* (5) Volunteer subjects and sign informed consent;
* (6) Can cooperate with the completion of this study.
Exclusion Criteria:
* (1) During pregnancy or lactation;
* (2) Patients with secondary RBD associated with narcolepsy or antidepressant use;
* (3) Patients with severe anxiety, depression and other mental diseases, alcohol abuse and/or psychoactive drug use, drug abusers and dependents;
* (4) Patients with serious underlying diseases, especially unstable diseases (such as malignant tumors, chronic obstructive pulmonary disease, unstable heart disease, etc.);
* (5) Patients with coagulation dysfunction, skin infection or damage at the surgical site should not receive acupuncture.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06606418
Study Brief:
Protocol Section:
NCT06606418