Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment

Amputees Clinical Trial

Official title:

Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02838485
• Other study ID #: Mirror- HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 17, 2016
• Last updated: July 17, 2016
• Start date: August 2016

Study information

• Verified date: July 2016
• Source: Hadassah Medical Organization
• Contact: Isabella Schwartz, MD
• Email: isabellas[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Description:

Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional one-meeting study of 20 subjects (finger amputees) in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Following unilateral traumatic finger or fingers amputation (1 to 3 fingers)

• Self-reported limited functionality, sensory disorder or pain

Exclusion Criteria:

• Are not comparable with MRI restrictions

• Chronic pain disease

• Psychiatric condition

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Amputees

Intervention

Other:
• Mirror
The healthy hand will be mirrored and the amputated hand unseen by the subject while performing hand movements.
• Imagery
The subject will be asked to imagine performing hand movements.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

Deconinck FJ, Smorenburg AR, Benham A, Ledebt A, Feltham MG, Savelsbergh GJ. Reflections on mirror therapy: a systematic review of the effect of mirror visual feedback on the brain. Neurorehabil Neural Repair. 2015 May;29(4):349-61. doi: 10.1177/1545968314546134. Epub 2014 Aug 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical activity	Activation of supplementary motor area (SMA), S1 and M1.	1 hour	No
Secondary	Visual analogue scale	Filled by the subject for subjective pain in residuum discomfort.	10 minutes	No
Secondary	Disability of the Arm, Shoulder and Hand	Questionnaire regarding the disability and daily activities difficulties.	30 minutes	No
Secondary	The Jebsen Taylor Hand Function Test	Standard evaluation of hands functionality.	30 minutes	No