Clinical trial NCT03661021: Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders
Official title: Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Movement Disorder
Keywords: Functional movement disorder
Functional neurological disorder
FMD
Psychogenic movement disorder
Movement Disorders
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Functional or Organic movement disorders at Cleveland Clinic Center for Neurological Restoration

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

1. 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
2. Patients with mild to severe involuntary movement as a result of the movement disorder, visible for video-recording.

Exclusion Criteria:

1. Significant cognitive impairment that prevents proper informed consent
2. Patients whose movement disorders cannot be captured on video

Primary outcomes:
measure: Change in Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters between two conditions in FMD vs OrgMD patients.
timeFrame: 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:
measure: The difference in the numerical change in self-perception of movement severity between two conditions in FMD vs OrgMD patients
timeFrame: 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
Other outcomes:
measure: Correlation between severity of depression or anxiety using PHQ-SADS scale and degree of change in severity of abnormal movement
timeFrame: 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
measure: Correlation between health care utilization using Health Care Utilization scale and degree of change in severity of abnormal movement
timeFrame: 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
measure: Correlation between illness belief/diagnosis agreement using B-IPQ and Agreement with Diagnosis scales and degree of change in severity of abnormal movement
timeFrame: 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
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Xin Xin Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hinson VK, Haren WB. Psychogenic movement disorders. Lancet Neurol. 2006 Aug;5(8):695-700. doi: 10.1016/S1474-4422(06)70523-3.
citation: Voon 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.
citation: van 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.
citation: de 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.
citation: Sitek 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.
citation: Amanzio 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.
citation: Straumann 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.
citation: Landers DM, McCullagh PD. Social facilitation of motor performance. Exerc Sport Sci Rev. 1976;4:125-62. No abstract available.
citation: Nielsen 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.