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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

October 25, 2011
October 14, 2014
October 2011
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01462461 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Virtual Integrated Environment in Decreasing Phantom Limb Pain
Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Phantom Limb
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.
Experimental: VIE Therapy
Intervention: Device: Virtual Integration Environment (VIE)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01462461
20448, W81XWH-09-2-0148
No
Henry M. Jackson Foundation for the Advancement of Military Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine
Johns Hopkins University
Principal Investigator: Paul F Pasquina, MD, MC Walter Reed National Military Medical Center (WRNMMC)
Henry M. Jackson Foundation for the Advancement of Military Medicine
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP