Phantom LimbVIENCT01462461
Virtual Integrated Environment in Decreasing Phantom Limb Pain
An observational study of Phantom Limb, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seven unilateral, upper-extremity amputees completed the study. These subjects were either trans-radial (n=4) or trans-humeral (n=3) amputees.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
About this study
Official title: 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.
Read the 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.
- Conditions
- Phantom Limb
- Keywords
- Phantom Limb, Amputation, Traumatic, Electromyography, Visual Analog Pain Scale
- Medical subject headings
- Phantom Limb, Amputation, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 weeks) and 4 weeks
Secondary outcomes (1)
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.
Measured: Baseline (0 weeks) and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Phantom LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Paul F Pasquina, MD, MC, Principal investigator, Walter Reed National Military Medical Center (WRNMMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462461
- Sponsor's protocol ID
- 20448
- Other IDs
- W81XWH-09-2-0148
- Acronym
- VIE
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2011
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8637922Ramachandran 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.
PubMed 9762952Carlen 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.
PubMed 564474Chan 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.
PubMed 18032777Hauschild 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.
PubMed 17436870Zeher 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.
PubMed 21335889
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT01462461
- Acronym / sponsor ID
- VIE / 20448
- Conditions
- Phantom Limb
- Keywords
- Phantom Limb, Amputation, Traumatic, Electromyography, Visual Analog Pain Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seven unilateral, upper-extremity amputees completed the study. These subjects were either trans-radial (n=4) or trans-humeral (n=3) amputees.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Consistency of sEMG recordings
Time frame: Baseline (0 weeks) and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Background: PubMed 8637922Ramachandran 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.
- Background: PubMed 9762952Ramachandran 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.
- Background: PubMed 564474Carlen 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.
- Background: PubMed 18032777Chan 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.
- Background: PubMed 17436870Hauschild 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.
- Background: PubMed 21335889Zeher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Pasquina, MD, MC principal investigator
Walter Reed National Military Medical Center (WRNMMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Limb, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phantom Limb Pain Severity (time frame: Baseline (0 weeks) and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01462461, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.