Examining Brain Changes Using Functional Magnetic Resonance Imaging (fMRI) in Amputees With Phantom Limb Pain Following Mirror Therapy

Status unconfirmed · Not applicable

Conditions studied: Phantom Limb Pain

In brief

Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid impression that the limb not only still is present, but also in many cases, painful. Preliminary data from study WRAMC WU# 05-71034, "Pilot study to assess the efficacy of mirror-box and mental visualization treatments on phantom limb pain" demonstrates that 4 weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that vision is a key component modulating PLP and may be the explanation for the efficacy of mirror therapy, as subjects view the reflected image of their intact limb while attempting to move the amputated, or phantom, limb. We propose conducting a study using functional magnetic resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to study the relationship of visual activation to the sensation of phantom pain. Subjects will have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain.

Key facts

Study ID

NCT00662415

Run by

United States Department of Defense

People needed

42

Starts

2008-02-01

Expected to finish

2010-02-01

Last updated by the study team

2008-04-21

Who can join

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

You may qualify if…

• For Amputee Subjects:
• Male or female subjects
• 18 to 75 years of age
• Active duty military
• Military healthcare beneficiary
• Military retiree
• Written informed consent and written authorization for use or release of health and research study information
• Unilateral lower limb amputation
• Right-handed
• Any level of prosthetic experience
• No prior history of vertebral disk disease/condition
• Sciatica
• Radiculopathy
• Neurological examination that will not interfere with participation in the study
• Minimum of 3 phantom limb pain episodes each week
• Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into study.
• Ability to follow study instructions and likely to complete all required visits
• For Control Subjects:
• Male or female subjects
• 18 to 75 years of age
• Written informed consent and written authorization for use or release of health and research study information
• Right-handed.
• No prior history of vertebral disk disease/condition
• Sciatica
• Radiculopathy

You may not qualify if…

• For Amputee Subjects:
• Age less than 18 or greater than 75 years
• Unilateral upper limb or multiple limb amputation.
• Amputation due to diabetes or vascular claudication
• No known pending revision surgeries
• Presence of embedded metallic shrapnel or other metal not compatible with MRI scanning
• Presence of traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening, including DVBIC testing, which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record
• 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
• Significant 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
• For Control Subjects:
• Age less than 18 or greater than 75 years
• Presence of an amputation
• Presence of embedded metallic shrapnel or other metal not compatible with MRI scanning
• Presence of traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record
• Known uncontrolled systemic disease- known cancer not in remission
• Known on-going infection
• Lupus
• Kidney disease requiring dialysis

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• National Institutes of Health — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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