Clinical trial NCT04565080: Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
Official title: Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Functional Movement Disorders
COVID-19
Keywords: Parkinson's Disease
Functional Movement Disorders
COVID-19
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-09-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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

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

Eligibility 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

Primary outcomes:
measure: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.
timeFrame: December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Mark Hallett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: