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

July 13, 2023 updated by: Xin Xin Yu, MD, The Cleveland Clinic
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between severity of depression or anxiety using PHQ-SADS scale and degree of change in severity of abnormal movement
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
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
Correlation between health care utilization using Health Care Utilization scale and degree of change in severity of abnormal movement
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
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
Correlation between illness belief/diagnosis agreement using B-IPQ and Agreement with Diagnosis scales and degree of change in severity of abnormal movement
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Xin Xin Yu, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sante-Fe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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