Virtual Integrated Environment in Decreasing Phantom Limb Pain (VIE)

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01462461
First received: October 25, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Phantom Limb
Device: Virtual Integration Environment (VIE)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain

Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • Change in Phantom Limb Pain Severity [ Time Frame: Baseline (0 weeks) and 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Consistency of sEMG recordings [ Time Frame: Baseline (0 weeks) and 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIE Therapy Device: Virtual Integration Environment (VIE)
The John Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a virtual reality system that allows patients to observe movement of a 3D virtual arm. The VIE also contains hardware and software for recording and processing surface electromyography (sEMG) signals from the residual 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462461

Locations
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
Investigators
Principal Investigator: Paul F Pasquina, MD, MC Walter Reed National Military Medical Center (WRNMMC)
  More Information

Publications:
Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01462461     History of Changes
Other Study ID Numbers: 20448, W81XWH-09-2-0148
Study First Received: October 25, 2011
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Phantom Limb
Amputation, Traumatic
Electromyography
Visual Analog Pain Scale

Additional relevant MeSH terms:
Phantom Limb
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014