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Completed

NCT Number: NCT04565080

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 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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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2020
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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