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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
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief 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


Condition or disease
Parkinson's Disease Functional Movement Disorders COVID-19

Detailed 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

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Study Type : Observational
Estimated Enrollment : 150 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)
Estimated Study Start Date : December 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort
FMD Patients
adult FMD patients who participated in protocol 07-N-0190
PD Patients
adult PD patients who participated in protocol 01-N-0206



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
PD patients: adults with clinical diagnosis of Parkinson s Disease as confirmed by a movement disorders specialist in patient s previously enrolled in protocol 01-N-0206.FMD patients: adults with clinical diagnosis of Functional movement disorder as confirmed by a movement disorders specialist in patient s previously enrolled in protocol 07-N-0190.
Criteria
  • 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


Information from the National Library of Medicine

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


Contacts
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Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
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United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS) Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
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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 3, 2020
Last Verified: September 22, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Parkinson's Disease
Functional Movement Disorders
COVID-19
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Disease
Conversion Disorder
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Somatoform Disorders
Mental Disorders