Mirror Therapy for Phantom Limb Pain

Completed

Conditions studied: Amputation

In brief

This study, conducted at the National Institutes of Health (NIH) and at Walter Reed Army Medical Center (WRAMC), will explore the phenomenon of phantom limb pain (a continued feeling of pain in an amputated limb) and will use functional magnetic resonance imaging (fMRI) to investigate the effect of mirror therapy on phantom limb pain. Right-handed people between 18 and 75 years of age who are in the WRAMC Military Amputee Research Program and healthy control subjects may be eligible for this study. Participants undergo the following procedures: Amputees * Questionnaires to assess strength of handedness and footedness and pain perception. * Mirror therapy for phantom limb pain five times a week for 4 weeks in 15-minute sessions. * MRI and fMRI scans before starting mirror therapy, after 2 weeks of therapy and after 4 weeks of therapy. MRI uses a magnetic field and radio waves to image brain tissue. The subject lies on a table that can slide in and out of the scanner (a metal cylinder). The structural MRI scan lasts about 30 minutes. For fMRI, the subject performs tasks while in the scanner in order to show changes in brain activity involved in performing those tasks. Subjects are shown pictures of feet and other body parts, are asked to move their feet, and receive tactile (touch) stimulation of the foot or other body parts. Control Subjects One group of control subjects undergoes a single fMRI procedure. A second group of control subjects undergoes the same sequence of three fMRIs over the same time period as the amputee subjects. None of the control subjects undergo mirror therapy. ...

Key facts

Study ID: NCT00623818
Run by: National Institute of Mental Health (NIMH)
People needed: 45
Starts: 2008-03-05
Expected to finish: 2019-12-10
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

For amputee subjects with PLP:
Age less than 18 or greater than 75 years.
Multiple limb amputation
Amputation due to diabetes or vascular claudication
Pending revision surgeries.
Presence of embedded metallic shrapnel or other metal not compatible with MRIscanning.
Presence of traumatic brain injury
Known uncontrolled systemic disease- known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Current Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering.
Positive pregnancy test at the time of scanning (within 24 hours prior to the scheduled MRI scan, female subjects of child-bearing age will be given a pregnancy test)
For amputee subjects without PLP:
Age less than 18 or greater than 75 years.
Multiple limb amputation.
Amputation due to diabetes or vascular claudication
Pending revision surgeries.
Presence of embedded metallic shrapnel or other metal not compatible with MRI scanning.
Presence of traumatic brain injury
Known uncontrolled systemic disease- known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Current Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering.

Where it is running

Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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