Functional Movement DisorderSante-FeNCT03661021
Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders
An observational study of Functional Movement Disorder, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Sante Fe is an investigation of a new technique to distinguish between different types of movement disorders, specifically organic versus functional, by observing changes in involuntary movements in two different situations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Functional Movement Disorder
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 22 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with Functional or Organic movement disorders at Cleveland Clinic Center for Neurological Restoration
Who may be able to join
- Patients with a clinical diagnosis of Functional Movement Disorder (e.g. functional tremor, functional dystonia, functional myoclonus) based on Fahn-Williams criteria or OrgMD (e.g. Parkinson disease, essential tremor, cervical dystonia) evaluated by a fellowship-trained movement disorder neurologist at Cleveland Clinic
- Patients with mild to severe involuntary movement as a result of the movement disorder, visible for video-recording.
Who cannot join
- Significant cognitive impairment that prevents proper informed consent
- Patients whose movement disorders cannot be captured on video
Trial locations and contacts
1 site in 1 country.
About this study
Sante Fe is an investigation of a new technique to distinguish between different types of movement disorders, specifically organic versus functional, by observing changes in involuntary movements in two different situations.
Read the detailed description
This study involves a short, one-time visit. Subjects will be asked to undergo a brief neurological examination while being video taped in two different scenarios. The severity of the abnormal movement will be analyzed and compared among subjects with functional (FMD) versus organic movement disorders (OrgMD).
- Conditions
- Functional Movement Disorder
- Keywords
- Functional movement disorder, Functional neurological disorder, FMD, Psychogenic movement disorder, Movement Disorders
- Medical subject headings
- Conversion Disorder, Movement Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients.
Change in Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients. Score reports total abnormal movement score ranging from 0-3 for 9 different regions of the body or body functions. Higher score implies more severe movement.
Measured: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 40 subjects and completing analysis with projected finish date in 1 year
Secondary outcomes (1)
The difference in the numerical change in self-perception of movement severity between two conditions in FMD vs OrgMD patients
The difference in the numerical change in self-perception of movement severity, as measured by a Likert-style scale, between two conditions in FMD vs OrgMD patients. Self-perception is scored on a scale of 0-4, with a higher score indicating more severe abnormal movement.
Measured: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 40 subjects and completing analysis with projected finish date in 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start18 Jul 2018
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Xin Yu, MD, The Cleveland Clinic
- Investigators
- Xin Xin Yu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661021
- Sponsor's protocol ID
- Sante-Fe
- Acronym
- Sante-Fe
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hinson VK, Haren WB. Psychogenic movement disorders. Lancet Neurol. 2006 Aug;5(8):695-700. doi: 10.1016/S1474-4422(06)70523-3.
PubMed 16857575Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5.
PubMed 20371508van Poppelen D, Saifee TA, Schwingenschuh P, Katschnig P, Bhatia KP, Tijssen MA, Edwards MJ. Attention to self in psychogenic tremor. Mov Disord. 2011 Dec;26(14):2575-6. doi: 10.1002/mds.23911. Epub 2011 Oct 24. No abstract available.
PubMed 22025317de Lange FP, Roelofs K, Toni I. Increased self-monitoring during imagined movements in conversion paralysis. Neuropsychologia. 2007 May 15;45(9):2051-8. doi: 10.1016/j.neuropsychologia.2007.02.002. Epub 2007 Feb 11.
PubMed 17367826Sitek EJ, Slawek J, Wieczorek D. [Self-awareness of deficits in Huntington's and Parkinson's disease]. Psychiatr Pol. 2008 May-Jun;42(3):393-403. Polish.
PubMed 19899567Amanzio M, Monteverdi S, Giordano A, Soliveri P, Filippi P, Geminiani G. Impaired awareness of movement disorders in Parkinson's disease. Brain Cogn. 2010 Apr;72(3):337-46. doi: 10.1016/j.bandc.2009.10.011. Epub 2009 Nov 14.
PubMed 19914762Straumann C, Anderson JR. Mirror-induced social facilitation in stumptailed macaques (Macaca arctoides). Am J Primatol. 1991;25(2):125-132. doi: 10.1002/ajp.1350250206.
PubMed 31948184Landers DM, McCullagh PD. Social facilitation of motor performance. Exerc Sport Sci Rev. 1976;4:125-62. No abstract available.
PubMed 798687Nielsen G, Ricciardi L, Meppelink AM, Holt K, Teodoro T, Edwards M. A Simplified Version of the Psychogenic Movement Disorders Rating Scale: The Simplified Functional Movement Disorders Rating Scale (S-FMDRS). Mov Disord Clin Pract. 2017 Mar 11;4(5):710-716. doi: 10.1002/mdc3.12475. eCollection 2017 Sep-Oct.
PubMed 30363505
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders
- ClinicalTrials.gov ID
- NCT03661021
- Acronym / sponsor ID
- Sante-Fe / Sante-Fe
- Conditions
- Functional Movement Disorder
- Keywords
- Functional movement disorder, Functional neurological disorder, FMD, Psychogenic movement disorder, Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 7 Sep 2018 (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.
Sante Fe is an investigation of a new technique to distinguish between different types of movement disorders, specifically organic versus functional, by observing changes in involuntary movements in two different situations.
Detailed description
This study involves a short, one-time visit. Subjects will be asked to undergo a brief neurological examination while being video taped in two different scenarios. The severity of the abnormal movement will be analyzed and compared among subjects with functional (FMD) versus organic movement disorders (OrgMD).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Functional or Organic movement disorders at Cleveland Clinic Center for Neurological Restoration
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of Functional Movement Disorder (e.g. functional tremor, functional dystonia, functional myoclonus) based on Fahn-Williams criteria or OrgMD (e.g. Parkinson disease, essential tremor, cervical dystonia) evaluated by a fellowship-trained movement disorder neurologist at Cleveland Clinic
- Patients with mild to severe involuntary movement as a result of the movement disorder, visible for video-recording.
Key exclusion criteria (2 listed)
- Significant cognitive impairment that prevents proper informed consent
- Patients whose movement disorders cannot be captured on video
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 Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients.
Time frame: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 40 subjects and completing analysis with projected finish date in 1 year
Change in Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients. Score reports total abnormal movement score ranging from 0-3 for 9 different regions of the body or body functions. Higher score implies more severe movement.
1 secondary outcome
The difference in the numerical change in self-perception of movement severity between two conditions in FMD vs OrgMD patients
Time frame: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 40 subjects and completing analysis with projected finish date in 1 year
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 13 Feb 2025.
- Background: PubMed 16857575Hinson VK, Haren WB. Psychogenic movement disorders. Lancet Neurol. 2006 Aug;5(8):695-700. doi: 10.1016/S1474-4422(06)70523-3.
- Background: PubMed 20371508Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5.
- Background: PubMed 22025317van Poppelen D, Saifee TA, Schwingenschuh P, Katschnig P, Bhatia KP, Tijssen MA, Edwards MJ. Attention to self in psychogenic tremor. Mov Disord. 2011 Dec;26(14):2575-6. doi: 10.1002/mds.23911. Epub 2011 Oct 24. No abstract available.
- Background: PubMed 17367826de Lange FP, Roelofs K, Toni I. Increased self-monitoring during imagined movements in conversion paralysis. Neuropsychologia. 2007 May 15;45(9):2051-8. doi: 10.1016/j.neuropsychologia.2007.02.002. Epub 2007 Feb 11.
- Background: PubMed 19899567Sitek EJ, Slawek J, Wieczorek D. [Self-awareness of deficits in Huntington's and Parkinson's disease]. Psychiatr Pol. 2008 May-Jun;42(3):393-403. Polish.
- Background: PubMed 19914762Amanzio M, Monteverdi S, Giordano A, Soliveri P, Filippi P, Geminiani G. Impaired awareness of movement disorders in Parkinson's disease. Brain Cogn. 2010 Apr;72(3):337-46. doi: 10.1016/j.bandc.2009.10.011. Epub 2009 Nov 14.
- Background: PubMed 31948184Straumann C, Anderson JR. Mirror-induced social facilitation in stumptailed macaques (Macaca arctoides). Am J Primatol. 1991;25(2):125-132. doi: 10.1002/ajp.1350250206.
- Background: PubMed 798687Landers DM, McCullagh PD. Social facilitation of motor performance. Exerc Sport Sci Rev. 1976;4:125-62. No abstract available.
- Background: PubMed 30363505Nielsen G, Ricciardi L, Meppelink AM, Holt K, Teodoro T, Edwards M. A Simplified Version of the Psychogenic Movement Disorders Rating Scale: The Simplified Functional Movement Disorders Rating Scale (S-FMDRS). Mov Disord Clin Pract. 2017 Mar 11;4(5):710-716. doi: 10.1002/mdc3.12475. eCollection 2017 Sep-Oct.
- Individual participant dataSharing planned: No
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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.
Xin Xin Yu, MD principal investigator
The Cleveland Clinic
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 Functional Movement Disorder, run by The Cleveland Clinic 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 2 inclusion and 2 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 13 Feb 2025. 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 Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients. (time frame: Because this is a one-time visit study, outcome will be measured during the visit, data reported at study conclusion after successfully recruiting 40 subjects and completing analysis with projected finish date in 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661021, which also lists 9 linked publications.
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 13 Feb 2025.