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NCT04565080 · ClinicalTrials.gov registry record
Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 44
- Enrollment target
NCT04565080: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT04565080 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565080 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD). Primary objectives: To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients. Secondary objectives: * To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients * To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change Exploratory objectives: * To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains * To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains * To evaluate whether there is a correlation between changes across symptom domains * To evaluate whether there is a correlation in raw score across symptom domains within each period Research Methods: Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire. Questionnaire items A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD. The questionnaire items include: Items investigating Mood/Energy before and after COVID 19 out break Items investigating Sleep habits before and after COVID 19 out break Items investigating Neurological symptoms before and after COVID 19 out break Items investigating daily functioning before and after COVID 19 out break Items investigating Exercise habits before and after COVID 19 out break No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety r
Primary Outcome
Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2021-08-02 |
What the finished NCT04565080 record still lists
NCT04565080 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04565080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04565080 about?
NCT04565080 is a clinical study titled "Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)". The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD). Primary objectives: To evaluate the change in neurological symptoms domain of the survey between pre and pos...
What is the current status of trial NCT04565080?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2020-10-29. Estimated completion is 2021-08-02.
Who is sponsoring clinical trial NCT04565080?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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