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

December 21, 2021 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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 Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Neurological Disorders and Stroke (NINDS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000159
  • 000159-N

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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