COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Virtual Integrated Environment in Decreasing Phantom Limb Pain (VIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01462461
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : October 16, 2015
Johns Hopkins University
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Condition or disease
Phantom Limb

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain
Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Primary Outcome Measures :
  1. Change in Phantom Limb Pain Severity [ Time Frame: Baseline (0 weeks) and 4 weeks ]
    Severity of PLP will be assessed using the Visual Analog Scale (VAS), which wil consist of a 10-cm horizontal line across which subjects will place a mark corresponding to the level of phantom limb pain he or she experiences. The distance in centimeters from the low end of the VAS to the subject's mark will be used as a numeric index of pain severity. The VAS score over 4 weeks of VIE treatment will be averaged and compared to the baseline VAS score at the start of treatment.

Secondary Outcome Measures :
  1. Consistency of sEMG recordings [ Time Frame: Baseline (0 weeks) and 4 weeks ]
    The activation patterns of muscles on an around the residual limb will be recorded during the initial VIE therapy session using surface electrodes. The sEMG recordings after 4 weeks will be compared to the initial sEMG recordings at the start of VIE treatment. The change in sEMG signals over time will indicate how well patients are able to replicate muscle activation patterns between sessions in which they attempt to move the phantom arm in the same manner as the virtual arm.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Seven unilateral, upper-extremity amputees completed the study. These subjects were either trans-radial (n=4) or trans-humeral (n=3) amputees.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01462461

Layout table for location information
United States, Maryland
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Paul F Pasquina, MD, MC Walter Reed National Military Medical Center (WRNMMC)
Layout table for additonal information
Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine Identifier: NCT01462461    
Other Study ID Numbers: 20448
W81XWH-09-2-0148 ( Other Grant/Funding Number: Henry M. Jackson Foundation )
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Phantom Limb
Amputation, Traumatic
Visual Analog Pain Scale
Additional relevant MeSH terms:
Layout table for MeSH terms
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms