Sante-Fe: Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders

Sponsor

The Cleveland Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03661021

Collaborator

(none)

Enrollment

Location

64.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Movement Disorder

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

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 18, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Change in Simplified Functional Movement Disorders Rating Scale (sFMDRS) score according to video raters 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]
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.

Secondary Outcome Measures

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]
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.

Other Outcome Measures

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 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.
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 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.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.