Status:
UNKNOWN
Examining Brain Changes Using Functional Magnetic Resonance Imaging (fMRI) in Amputees With Phantom Limb Pain Following Mirror Therapy
Lead Sponsor:
United States Department of Defense
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a prospective trial that will use fMRI to identify brain regions critical to the generation of PLP, examine the role of mirror therapy and the visual system in the de-activation of pain pathwa...
Eligibility Criteria
Inclusion
- 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
- Normal neurological examination
- Ability to follow study instructions and likely to complete all required visits
Exclusion
- 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
- Any other systemic disease which might affect ability to participate in this study to its conclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00662415
Start Date
February 1 2008
End Date
February 1 2010
Last Update
April 21 2008
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
2
National Institutes of Health
Bethesda, Maryland, United States, 20892