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

NCT04565080 | Completed

• 2 other identifiers: 10000159000159-N
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease; Functional Movement Disorders; COVID-19

Keywords

Parkinson's Disease; Functional Movement Disorders; COVID-19; Natural History

Outcome Measures

Primary Outcomes (1)

• Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

  Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

  December 2021

Study Arms (2)

FMD Patients

adult FMD patients who participated in protocol 07-N-0190

PD Patients

adult PD patients who participated in protocol 01-N-0206

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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

You may not qualify if:

• N/A

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Conversion Disorder; COVID-19

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Somatoform Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: October 29, 2020
• Primary Completion: March 4, 2021
• Study Completion: August 2, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

US (1)