Virtual Integrated Environment in Decreasing Phantom Limb Pain

Phantom Limb Clinical Trial

— VIE  

Official title:

Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462461
• Other study ID #: 20448
• Secondary ID: W81XWH-09-2-0148
• Status: Completed
• Phase: N/A
• First received: October 25, 2011
• Last updated: October 14, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Phantom Limb

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center (WRNMMC)	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. — View Citation

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. — View Citation

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. — View Citation

Ramachandran VS, Hirstein W. The perception of phantom limbs. The D. O. Hebb lecture. Brain. 1998 Sep;121 ( Pt 9):1603-30. Review. — View Citation

Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Phantom Limb Pain Severity	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.	Baseline (0 weeks) and 4 weeks	No
Secondary	Consistency of sEMG recordings	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.	Baseline (0 weeks) and 4 weeks	No