NCT02838485

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 17, 2016

Last Update Submit

July 17, 2016

Conditions

Amputees

Outcome Measures

Primary Outcomes (1)

  • Cortical activity

    Activation of supplementary motor area (SMA), S1 and M1.

    1 hour

Secondary Outcomes (3)

  • Visual analogue scale

    10 minutes

  • Disability of the Arm, Shoulder and Hand

    30 minutes

  • The Jebsen Taylor Hand Function Test

    30 minutes

Study Arms (1)

Amputees

EXPERIMENTAL

The subjects will receive both mirror and imagery treatments in a cross-over design.

Other: MirrorOther: Imagery

Interventions

MirrorOTHER

The healthy hand will be mirrored and the amputated hand unseen by the subject while performing hand movements.

Amputees
ImageryOTHER

The subject will be asked to imagine performing hand movements.

Amputees

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Following unilateral traumatic finger or fingers amputation (1 to 3 fingers)
  • Self-reported limited functionality, sensory disorder or pain

You may not qualify if:

  • Are not comparable with MRI restrictions
  • Chronic pain disease
  • Psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91240, Israel

Location

Related 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. doi: 10.1056/NEJMc071927. No abstract available.

    PMID: 18032777BACKGROUND

  • 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.

    PMID: 25160567BACKGROUND

Central Study Contacts

Isabella Schwartz, MD

CONTACT

isabellas@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2016

First Posted

July 20, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

IL(1)