An observational study in Parkinson's Disease, Functional Movement Disorders and COVID-19, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-22.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
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:
Exploratory objectives:
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
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:
Exploratory objectives:
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 44 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
(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
EXCLUSION CRITERIA:
N/A
adult FMD patients who participated in protocol 07-N-0190
adult PD patients who participated in protocol 01-N-0206
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.
Time frame: December 2021
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Neurological Disorders and Stroke (NINDS)