Virtual Integrated Environment in Decreasing Phantom Limb Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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Nearly all traumatic limb amputees will experience cognizance of a phantom limb and perceive a vivid impression that their lost limb is not only fully present, but also painful. The John Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a highly flexible and adaptable virtual reality system that allows patients to observe movement of a 3D virtual arm. Using the VIE, recorded signals from the residual limb will be correlated to the desired motion of the phantom limb. We hope to correlate the consistency of these patterns with PLP to determine if increased control of the phantom limb leads to decreased PLP.

Conditions

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Phantom Limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes