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NCT04565080 Clinical Trial

Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)

COVID-19 Clinical Trial

Official title:
Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04565080
Other study ID # 10000159
Secondary ID 000159-N
Status Completed
Phase
First received
Last updated
Start date October 29, 2020
Est. completion date August 2, 2021

Study information
Verified date December 2021
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 requiring urgent and immediate medical or psychiatric

Description:

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 requiring urgent and immediate medical or psychiatric

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date August 2, 2021
Est. primary completion date March 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA: 1. (for FMD subjects only) Clinical diagnosis of Functional movement disorder as confirmed by a movement disorders specialist in subjects previously enrolled in protocol 07-N-0190 2. (for PD subjects only) Clinical diagnosis of Parkinson s Disease as confirmed by a movement disorders specialist in subjects previously enrolled in protocol 01-N-0206. 3. Able to give informed consent 4. Male or female, age 18 and above 5. Have access to the internet in order to fill out the survey 6. Have enough fluency in English to be able to read the consent form and take the survey in English EXCLUSION CRITERIA: N/A

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients. Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients. December 2021
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