NCT00662415

Brief Summary

Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid impression that the limb not only still is present, but also in many cases, painful. Preliminary data from study WRAMC WU# 05-71034, "Pilot study to assess the efficacy of mirror-box and mental visualization treatments on phantom limb pain" demonstrates that 4 weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that vision is a key component modulating PLP and may be the explanation for the efficacy of mirror therapy, as subjects view the reflected image of their intact limb while attempting to move the amputated, or phantom, limb. We propose conducting a study using functional magnetic resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to study the relationship of visual activation to the sensation of phantom pain. Subjects will have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

March 14, 2008

Last Update Submit

April 14, 2008

Conditions

Phantom Limb Pain

Keywords

phantom limb painfMRImirror therapy

Outcome Measures

Primary Outcomes (2)

  • The identification of brain regions activated before and after treatment with mirror therapy.

    0, 2, and 4 weeks

  • phantom limb pain as measured using the VAS and McGill

    daily for 4 weeks

Study Arms (2)

1

OTHER

12 non-amputee control subjects will be scanned at 0, 2 and 4 weeks but will not recieve mirror therapy.

Behavioral: observation

2

EXPERIMENTAL

24 unilateral lower extremity amputee subjects will recieve daily mirror therapy for phantom limb pain and will be scanned at 0, 2, and 4 weeks.

Device: mirror-box treatment

Interventions

mirror-box treatmentDEVICE

15 minutes daily for 4 weeks

2
observationBEHAVIORAL

observation

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Amputee Subjects:
  • Male or female subjects
  • to 75 years of age
  • Active duty military
  • Military healthcare beneficiary
  • Military retiree
  • Written informed consent and written authorization for use or release of health and research study information
  • Unilateral lower limb amputation
  • Right-handed
  • Any level of prosthetic experience
  • No prior history of vertebral disk disease/condition
  • Sciatica
  • Radiculopathy
  • Neurological examination that will not interfere with participation in the study
  • Minimum of 3 phantom limb pain episodes each week
  • +12 more criteria

You may not qualify if:

  • For Amputee Subjects:
  • Age less than 18 or greater than 75 years
  • Unilateral upper limb or multiple limb amputation.
  • Amputation due to diabetes or vascular claudication
  • No known pending revision surgeries
  • Presence of embedded metallic shrapnel or other metal not compatible with MRI scanning
  • Presence of 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, including DVBIC testing, which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record
  • Known uncontrolled systemic disease- known cancer not in remission
  • Known on-going infection
  • Lupus
  • Kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
  • Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the 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 physiatrist
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

National Institutes of Health

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (28)

  • 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.

    PMID: 9762952BACKGROUND

  • Sherman RA, Sherman CJ, Parker L. Chronic phantom and stump pain among American veterans: results of a survey. Pain. 1984 Jan;18(1):83-95. doi: 10.1016/0304-3959(84)90128-3.

    PMID: 6709380BACKGROUND

  • Jensen TS, Krebs B, Nielsen J, Rasmussen P. Phantom limb, phantom pain and stump pain in amputees during the first 6 months following limb amputation. Pain. 1983 Nov;17(3):243-256. doi: 10.1016/0304-3959(83)90097-0.

    PMID: 6657285BACKGROUND

  • Browder J, Gallagher JP. Dorsal Cordotomy for Painful Phantom Limb. Ann Surg. 1948 Sep;128(3):456-69. doi: 10.1097/00000658-194809000-00011. No abstract available.

    PMID: 17859213BACKGROUND

  • Schug SA, Burrell R, Payne J, Tester P. Pre-emptive epidural analgesia may prevent phantom limb pain. Reg Anesth. 1995 May-Jun;20(3):256. No abstract available.

    PMID: 7547671BACKGROUND

  • Wall JT. Variable organization in cortical maps of the skin as an indication of the lifelong adaptive capacities of circuits in the mammalian brain. Trends Neurosci. 1988 Dec;11(12):549-57. doi: 10.1016/0166-2236(88)90184-1. No abstract available.

    PMID: 2471312BACKGROUND

  • Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.

    PMID: 7777055BACKGROUND

  • Grusser SM, Winter C, Muhlnickel W, Denke C, Karl A, Villringer K, Flor H. The relationship of perceptual phenomena and cortical reorganization in upper extremity amputees. Neuroscience. 2001;102(2):263-72. doi: 10.1016/s0306-4522(00)00491-7.

    PMID: 11166112BACKGROUND

  • Adrian ED, Zotterman Y. The impulses produced by sensory nerve-endings: Part II. The response of a Single End-Organ. J Physiol. 1926 Apr 23;61(2):151-71. doi: 10.1113/jphysiol.1926.sp002281. No abstract available.

    PMID: 16993780BACKGROUND

  • Garraghty PE, Kaas JH. Functional reorganization in adult monkey thalamus after peripheral nerve injury. Neuroreport. 1991 Dec;2(12):747-50. doi: 10.1097/00001756-199112000-00004.

    PMID: 1793816BACKGROUND

  • WIESEL TN, HUBEL DH. SINGLE-CELL RESPONSES IN STRIATE CORTEX OF KITTENS DEPRIVED OF VISION IN ONE EYE. J Neurophysiol. 1963 Nov;26:1003-17. doi: 10.1152/jn.1963.26.6.1003. No abstract available.

    PMID: 14084161BACKGROUND

  • Elbert T, Flor H, Birbaumer N, Knecht S, Hampson S, Larbig W, Taub E. Extensive reorganization of the somatosensory cortex in adult humans after nervous system injury. Neuroreport. 1994 Dec 20;5(18):2593-7. doi: 10.1097/00001756-199412000-00047.

    PMID: 7696611BACKGROUND

  • Lotze M, Laubis-Herrmann U, Topka H, Erb M, Grodd W. Reorganization in the primary motor cortex after spinal cord injury - A functional Magnetic Resonance (fMRI) study. Restor Neurol Neurosci. 1999;14(2-3):183-187.

    PMID: 12671262BACKGROUND

  • Merzenich MM, Nelson RJ, Stryker MP, Cynader MS, Schoppmann A, Zook JM. Somatosensory cortical map changes following digit amputation in adult monkeys. J Comp Neurol. 1984 Apr 20;224(4):591-605. doi: 10.1002/cne.902240408.

    PMID: 6725633BACKGROUND

  • Pons TP, Garraghty PE, Ommaya AK, Kaas JH, Taub E, Mishkin M. Massive cortical reorganization after sensory deafferentation in adult macaques. Science. 1991 Jun 28;252(5014):1857-60. doi: 10.1126/science.1843843.

    PMID: 1843843BACKGROUND

  • Ramachandran VS. Blind spots. Sci Am. 1992 May;266(5):86-91. doi: 10.1038/scientificamerican0592-86. No abstract available.

    PMID: 1566041BACKGROUND

  • 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.

    PMID: 8637922BACKGROUND

  • Franz EA, Ramachandran VS. Bimanual coupling in amputees with phantom limbs. Nat Neurosci. 1998 Oct;1(6):443-4. doi: 10.1038/2161. No abstract available.

    PMID: 10196540BACKGROUND

  • MacLachlan M, McDonald D, Waloch J. Mirror treatment of lower limb phantom pain: a case study. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):901-4. doi: 10.1080/09638280410001708913.

    PMID: 15497919BACKGROUND

  • Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77. doi: 10.1093/brain/124.11.2268.

    PMID: 11673327BACKGROUND

  • Lotze M, Grodd W, Birbaumer N, Erb M, Huse E, Flor H. Does use of a myoelectric prosthesis prevent cortical reorganization and phantom limb pain? Nat Neurosci. 1999 Jun;2(6):501-2. doi: 10.1038/9145. No abstract available.

    PMID: 10448212BACKGROUND

  • Bauer L, O'Bryant SE, Lynch JK, McCaffrey RJ, Fisher JM. Examining the Test Of Memory Malingering Trial 1 and Word Memory Test Immediate Recognition as screening tools for insufficient effort. Assessment. 2007 Sep;14(3):215-22. doi: 10.1177/1073191106297617.

    PMID: 17690378BACKGROUND

  • Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.

    PMID: 8008411BACKGROUND

  • Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

    PMID: 3670870BACKGROUND

  • Buccino G, Binkofski F, Fink GR, Fadiga L, Fogassi L, Gallese V, Seitz RJ, Zilles K, Rizzolatti G, Freund HJ. Action observation activates premotor and parietal areas in a somatotopic manner: an fMRI study. Eur J Neurosci. 2001 Jan;13(2):400-4.

    PMID: 11168545BACKGROUND

  • Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.

    PMID: 12204303BACKGROUND

  • Lenth RV. Statistical power calculations. J Anim Sci. 2007 Mar;85(13 Suppl):E24-9. doi: 10.2527/jas.2006-449. Epub 2006 Oct 23.

    PMID: 17060421BACKGROUND

  • Griffin SC, Curran S, Chan AWY, Finn SB, Baker CI, Pasquina PF, Tsao JW. Trajectory of phantom limb pain relief using mirror therapy: Retrospective analysis of two studies. Scand J Pain. 2017 Apr;15:98-103. doi: 10.1016/j.sjpain.2017.01.007. Epub 2017 Mar 7.

    PMID: 28850360DERIVED

MeSH Terms

Conditions

Phantom Limb

Interventions

Observation

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Jack W Tsao, MD

CONTACT

(301) 295-9684tsaoj@grc.nia.nih.gov

Christopher Baker, PhD

CONTACT

(301) 435-6058

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2008

First Posted

April 21, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

US(2)