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

NCT03661021 | Completed

• 1 other identifier: Sante-Fe
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Movement Disorder

Keywords

Functional movement disorder; Functional neurological disorder; FMD; Psychogenic movement disorder; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The difference in the numerical change in self-perception of movement severity between two conditions in FMD vs OrgMD patients

  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 (3)

• Correlation between severity of depression or anxiety using PHQ-SADS scale and degree of change in severity of 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

• Correlation between health care utilization using Health Care Utilization scale and degree of change in severity of 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

• Correlation between illness belief/diagnosis agreement using B-IPQ and Agreement with Diagnosis scales and degree of change in severity of 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Functional or Organic movement disorders at Cleveland Clinic Center for Neurological Restoration

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (9)

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

  PMID: 16857575 BACKGROUND

• 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.

  PMID: 20371508 BACKGROUND

• 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.

  PMID: 22025317 BACKGROUND

• 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.

  PMID: 17367826 BACKGROUND

• 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.

  PMID: 19899567 BACKGROUND

• 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.

  PMID: 19914762 BACKGROUND

• 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.

  PMID: 31948184 BACKGROUND

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

  PMID: 798687 BACKGROUND

• 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.

  PMID: 30363505 BACKGROUND

MeSH Terms

Conditions

Conversion Disorder; Movement Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xin Xin Yu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: September 7, 2018
• Study Start: July 18, 2018
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: February 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)