Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mirror Box Therapy as a Treatment Option for Functional Movement Disorders (MIMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660098
Recruitment Status : Suspended (Due to COVID-19 virus)
First Posted : September 6, 2018
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Xin Xin Yu, MD, The Cleveland Clinic

Brief Summary:
The purpose of this study is to investigate the potential of using mirror box therapy as a therapeutic technique amongst patients with functional movement disorders. It is hypothesized that a brief, single, in-office mirror therapy session will lead to a noticeable decrease in FMD-related involuntary movements.

Condition or disease
Functional Movement Disorder

Detailed Description:
Patients diagnosed with Functional Movement Disorder presenting with a unilateral or asymmetrical bilateral hand tremor will be asked to participate in a series of hand exercises with and without a mirror box. The severity of the tremor will be rated subjectively by the subject and objectively by the neurologist after hand exercises with and without the mirror box.

Layout table for study information
Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mirror Box Therapy as a Treatment Option for Functional Movement Disorders
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise [ 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 14 subjects and completing analysis with projected finish date in 1 year ]
    The difference in scored movement severity in the more affected hand based on the modified s-FMDRS scale during the Unified Parkinson's Disease Rating Scale (UPDRS) exam after the exercises with vs. without the mirror box. Movements are scored by video raters on a scale of 0-3, and higher score indicates more severe movement.


Secondary Outcome Measures :
  1. Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise [ 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 14 subjects and completing analysis with projected finish date in 1 year ]
    The difference in scored movement severity in the more affected hand based on the modified s-FMDRS scale with vs. without the mirror box during exercise. Movements are scored by video raters on a scale of 0-3, and a higher score indicates more severe movement.

  2. Change in self-perception [ 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 14 subjects and completing analysis with projected finish date in 1 year ]
    The difference in patient self-perception of movement severity based on a self-perception scale after the task with vs. without the mirror box. Patient scores movement on a scale of 0-4, with a higher score indicating more severe movement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with functional movement disorder (functional tremor) by a fellowship trained movement disorders neurologist
Criteria

Inclusion Criteria:

  1. Patients diagnosed with functional movement disorder by a fellowship trained movement disorders neurologist, presenting predominantly with unilateral or asymmetrical bilateral involuntary movement in the upper extremity
  2. In patients with bilateral involuntary movements, the symptoms in one arm must be minimal

Exclusion Criteria:

  1. Patients with moderate to severe involuntary movement in both arms
  2. Significant cognitive impairment that prevents proper informed consent
  3. Severe involuntary movement that interferes with the use of the apparatus
  4. Patients with hemiparesis or the loss of one arm due to various reasons (e.g. amputations, birth defects, etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660098


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Xin Xin Yu, MD The Cleveland Clinic
Publications:
Jacob A, Kaelin D, Smith C, Jablonski M, Roach A, LaFaver K. Motor retraining (MoRe) for functional movement disorders: Outcomes from a one-week multidisciplinary rehabilitation program (S4. 007). Neurology. 2017 Apr 18;88(16 Supplement):S4-007.
Jose N. Mirror Box Therapy. Int. J. Adv. Nur. Management. 2014 Apr;2(2):97-9.

Layout table for additonal information
Responsible Party: Xin Xin Yu, MD, Attending Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03660098    
Other Study ID Numbers: 18-458
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Xin Yu, MD, The Cleveland Clinic:
FMD
functional movement disorder
functional neurological disorder
functional tremor
psychogenic tremor
Additional relevant MeSH terms:
Layout table for MeSH terms
Movement Disorders
Disease
Conversion Disorder
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Somatoform Disorders
Mental Disorders