Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders

Functional Movement Disorder Clinical Trial

— Sante-Fe  

Official title:

Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03661021
• Other study ID #: Sante-Fe
• Status: Active, not recruiting
• Start date: July 18, 2018
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Movement Disorders

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View Citation

Hinson VK, Haren WB. Psychogenic movement disorders. Lancet Neurol. 2006 Aug;5(8):695-700. doi: 10.1016/S1474-4422(06)70523-3. — View Citation

Landers DM, McCullagh PD. Social facilitation of motor performance. Exerc Sport Sci Rev. 1976;4:125-62. No abstract available. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between severity of depression or anxiety using PHQ-SADS scale and degree of change in severity of abnormal movement	Correlation between severity of depression or anxiety using PHQ-SADS scale and degree of change in severity of abnormal movement. Scale includes three sets of questions relating to symptoms of anxiety and depression. Each symptom is scored on a range of 0-2 or 3 and summed. Higher score indicates higher levels of anxiety or depression symptoms.	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	Correlation between health care utilization using Health Care Utilization scale and degree of change in severity of abnormal movement	Correlation between health care utilization using Health Care Utilization scale and degree of change in severity of abnormal movement. Scale asks about number of health care related experiences in the past 6 months.	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	Correlation between illness belief/diagnosis agreement using B-IPQ and Agreement with Diagnosis scales and degree of change in severity of abnormal movement	Correlation between illness belief/diagnosis agreement using B-IPQ and Agreement with Diagnosis scales and degree of change in severity of abnormal movement. B-IPQ asks subjects to answer questions about the impact of their illness on their lives on a scale of 0-10, where higher implies greater impact. Agreement with Diagnosis scale asks FMD subjects to rate the confidence in their diagnosis on a scale of 0-10, with 10 implying full confidence.	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
Primary	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.	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	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.	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