Clinical trial NCT03660098: Mirror Box Therapy As a Treatment Option for Functional Movement Disorders
Official title: Mirror Box Therapy As a Treatment Option for Functional Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Movement Disorder
Keywords: FMD
functional movement disorder
functional neurological disorder
functional tremor
psychogenic tremor
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with functional movement disorder (functional tremor) by a fellowship trained movement disorders neurologist

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score post exercise
timeFrame: 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
Secondary outcomes:
measure: Change in Simplified Functional Movement Disorders Rating Scale (s-FMDRS) score during exercise
timeFrame: 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
measure: Change in self-perception
timeFrame: 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
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Xin Xin Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ricciardi L, Edwards MJ. Treatment of functional (psychogenic) movement disorders. Neurotherapeutics. 2014 Jan;11(1):201-7. doi: 10.1007/s13311-013-0246-x.
citation: Morgante F, Edwards MJ, Espay AJ. Psychogenic movement disorders. Continuum (Minneap Minn). 2013 Oct;19(5 Movement Disorders):1383-96. doi: 10.1212/01.CON.0000436160.41071.79.
citation: Jacob AE, Kaelin DL, Roach AR, Ziegler CH, LaFaver K. Motor Retraining (MoRe) for Functional Movement Disorders: Outcomes From a 1-Week Multidisciplinary Rehabilitation Program. PM R. 2018 Nov;10(11):1164-1172. doi: 10.1016/j.pmrj.2018.05.011. Epub 2018 May 18.
citation: Arya KN, Pandian S. Effect of task-based mirror therapy on motor recovery of the upper extremity in chronic stroke patients: a pilot study. Top Stroke Rehabil. 2013 May-Jun;20(3):210-7. doi: 10.1310/tsr2003-210.
citation: Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.
citation: Moseley LG, Gallace A, Spence C. Is mirror therapy all it is cracked up to be? Current evidence and future directions. Pain. 2008 Aug 15;138(1):7-10. doi: 10.1016/j.pain.2008.06.026. Epub 2008 Jul 14. No abstract available.
citation: Diers M, Christmann C, Koeppe C, Ruf M, Flor H. Mirrored, imagined and executed movements differentially activate sensorimotor cortex in amputees with and without phantom limb pain. Pain. 2010 May;149(2):296-304. doi: 10.1016/j.pain.2010.02.020. Epub 2010 Mar 31.
citation: Jose N. Mirror Box Therapy. Int. J. Adv. Nur. Management. 2014 Apr;2(2):97-9.
citation: Chatterjee P, Banerjee R, Choudhury S, Mondal B, Kulsum MU, Chatterjee K, Kumar H. Mirror movements in Parkinson's disease: An under-appreciated clinical sign. J Neurol Sci. 2016 Jul 15;366:171-176. doi: 10.1016/j.jns.2016.05.026. Epub 2016 May 14.