Tremography comparison of laboratory-grade and consumer product accelerometers in patients with essential tremor or Parkinson disease - Tremography comparison of accelerometers

Centre for Human Drug Research0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Signed informed consent prior to any study-mandated procedure;
•2. Male or female subject, 18 to 80 years of age (inclusive);
•a. Female participation is not limited to childbearing potential, or pregnancy or breast-feeding status;
•3. A diagnosis of either ET or PD according to the following criteria:
•a. ET diagnosis must fit the *classic ET* criteria, as describe by Deuschl et al. (Deuschl et al., 1998);
•b. PD diagnosis must fit the *established PD* or *probable PD* level, as defined by Postuma et al. (Postuma et al., 2015);
•i. Hoehn and Yahr stage must be * III;
•4. Tremor must be present in at least 1 hand, regardless of the current therapy;
•5. Otherwise healthy as is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and physical examination;
•6. Body mass index between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg;
•7. Ability to communicate well with the investigator in the Dutch language.

•1. Any known factor, concomitant diagnose(s) or disease(s) or condition(s), as judged by the investigator, that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study;
•2. Unacceptable non-pharmacological therapies at screening, e.g., radiotherapy in a cancer study;
•3. Unacceptable non-pharmacological use of substances at screening known or likely to interact with the study assessments (e.g., nicotine, alcohol, caffeine);
•4. Positive test for alcohol or drugs of abuse at screening;
•5. Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year;
•6. Unwillingness or inability to comply with the study protocol for any other reason, as judged by the investigator.

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