Parkinson's DiseaseNCT04565080
Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
An observational study of Parkinson's Disease and Functional Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Functional Movement Disorders, COVID-19
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 2 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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:
Read more
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
Read the 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
- Conditions
- Parkinson's Disease, Functional Movement Disorders, COVID-19
- Keywords
- Parkinson's Disease, Functional Movement Disorders, COVID-19, Natural History
- Medical subject headings
- Parkinson Disease, Conversion Disorder, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start29 Oct 2020
- Primary completion4 Mar 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565080
- Sponsor's protocol ID
- 10000159
- Other IDs
- 000159-N
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT04565080
- Acronym / sponsor ID
- 10000159
- Conditions
- Parkinson's Disease, Functional Movement Disorders, COVID-19
- Keywords
- Parkinson's Disease, Functional Movement Disorders, COVID-19, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMD Patients | – | –adult FMD patients who participated in protocol 07-N-0190 |
| PD Patients | – | –adult PD patients who participated in protocol 01-N-0206 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Functional Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients. (time frame: December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.