Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
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| ClinicalTrials.gov Identifier: NCT04565080 |
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Recruitment Status :
Completed
First Posted : September 25, 2020
Last Update Posted : December 22, 2021
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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
| Condition or disease |
|---|
| Parkinson's Disease Functional Movement Disorders COVID-19 |
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
| Study Type : | Observational |
| Actual Enrollment : | 44 participants |
| Observational Model: | Ecologic or Community |
| Time Perspective: | Cross-Sectional |
| Official Title: | Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD) |
| Actual Study Start Date : | October 29, 2020 |
| Actual Primary Completion Date : | March 4, 2021 |
| Actual Study Completion Date : | August 2, 2021 |
| Group/Cohort |
|---|
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FMD Patients
adult FMD patients who participated in protocol 07-N-0190
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PD Patients
adult PD patients who participated in protocol 01-N-0206
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- Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients. [ Time Frame: December 2021 ]Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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INCLUSION CRITERIA:
- (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
- (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.
- Able to give informed consent
- Male or female, age 18 and above
- Have access to the internet in order to fill out the survey
- Have enough fluency in English to be able to read the consent form and take the survey in English
EXCLUSION CRITERIA:
N/A
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565080
| United States, Maryland | |
| National Institute of Neurological Disorders and Stroke (NINDS) | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Mark Hallett, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
| Responsible Party: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT04565080 |
| Other Study ID Numbers: |
10000159 000159-N |
| First Posted: | September 25, 2020 Key Record Dates |
| Last Update Posted: | December 22, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Parkinson's Disease Functional Movement Disorders COVID-19 Natural History |
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COVID-19 Parkinson Disease Movement Disorders Disease Pathologic Processes Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Synucleinopathies Neurodegenerative Diseases |