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

NCT04565080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2021-12-22

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Mark Hallett, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-29
Primary Completion
2021-03-04
Completion
2021-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565080 on ClinicalTrials.gov