- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462461
Virtual Integrated Environment in Decreasing Phantom Limb Pain (VIE)
October 14, 2015 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center (WRNMMC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Phantom Limb Pain Severity
Time Frame: Baseline (0 weeks) and 4 weeks
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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.
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Baseline (0 weeks) and 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consistency of sEMG recordings
Time Frame: Baseline (0 weeks) and 4 weeks
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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.
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Baseline (0 weeks) and 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul F Pasquina, MD, MC, Walter Reed National Military Medical Center (WRNMMC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ramachandran VS, Hirstein W. The perception of phantom limbs. The D. O. Hebb lecture. Brain. 1998 Sep;121 ( Pt 9):1603-30. doi: 10.1093/brain/121.9.1603.
- Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
- Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.
- Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. doi: 10.1212/wnl.28.3.211.
- Hauschild M, Davoodi R, Loeb GE. A virtual reality environment for designing and fitting neural prosthetic limbs. IEEE Trans Neural Syst Rehabil Eng. 2007 Mar;15(1):9-15. doi: 10.1109/TNSRE.2007.891369.
- Zeher MJ, Armiger RS, Burck JM, Moran C, Kiely JB, Weeks SR, Tsao JW, Pasquina PF, Davoodi R, Loeb G. Using a virtual integration environment in treating phantom limb pain. Stud Health Technol Inform. 2011;163:730-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 25, 2011
First Submitted That Met QC Criteria
October 27, 2011
First Posted (Estimate)
October 31, 2011
Study Record Updates
Last Update Posted (Estimate)
October 16, 2015
Last Update Submitted That Met QC Criteria
October 14, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20448
- W81XWH-09-2-0148 (Other Grant/Funding Number: Henry M. Jackson Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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