- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838485
Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Isabella Schwartz, MD
- Email: isabellas@hadassah.org.il
Study Locations
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-
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Jerusalem, Israel, 91240
- Hadassah Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amputees
The subjects will receive both mirror and imagery treatments in a cross-over design.
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The healthy hand will be mirrored and the amputated hand unseen by the subject while performing hand movements.
The subject will be asked to imagine performing hand movements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical activity
Time Frame: 1 hour
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Activation of supplementary motor area (SMA), S1 and M1.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale
Time Frame: 10 minutes
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Filled by the subject for subjective pain in residuum discomfort.
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10 minutes
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Disability of the Arm, Shoulder and Hand
Time Frame: 30 minutes
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Questionnaire regarding the disability and daily activities difficulties.
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30 minutes
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The Jebsen Taylor Hand Function Test
Time Frame: 30 minutes
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Standard evaluation of hands functionality.
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30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Mirror- HMO-CTIL
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