Virtual Integrated Environment in Decreasing Phantom Limb Pain

Completed

Conditions studied: Phantom Limb

In brief

The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees.

Key facts

Study ID

NCT01462461

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

14

Starts

2011-10-01

Expected to finish

2014-01-01

Last updated by the study team

2015-10-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Walter Reed National Military Medical Center (WRNMMC) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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