The purpose of this study is to determine if observing a virtual arm decreases phantom limb
pain (PLP) in upper extremity amputees.
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Locations near you
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Full eligibility criteria for NCT01462461
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female subjects, 18 to 65 years of age, active duty military, beneficiary, or retiree.
Written informed consent and written authorization for use or release of health and research study information.
At least one upper-limb amputation (trans radial or trans humeral) at any time prior to enrollment.
No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
Normal neurological examination with the exception of limb amputation.
Ability to follow study instructions and likely to complete all required visits.
Experiencing PLP at least 3 times a week at an intensity of at least 3 out of 10 at the time of enrollment.
Presence of mild to severe 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 that is currently performed routinely on patients by the traumatic brain injury (TBI) program at Walter Reed National Military Medical Center (WRNMMC) and noted in the patient's medical record.
Known uncontrolled systemic disease
Participation (either concurrently or in the 30 days prior to enrollment) in another study for treatment of PLP
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound 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 psychiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) in order to exclude those with blatant exaggeration or malingering. Subjects who score lower than 42/50 on the TOMM-2 will not continue in the study
All locations for NCT01462461
United States (1)
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889
View full eligibility
Tris trial is registered with FDA with number: NCT01462461. The sponsor of the trial is Henry M. Jackson Foundation for the Advancement of Military Medicine and it is looking for 14 volunteers for the current phase.
Official trial title: Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain
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