Examining Brain Changes Using Functional Magnetic Resonance Imaging (fMRI) in Amputees With Phantom Limb Pain Following Mirror Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00662415
First received: March 14, 2008
Last updated: April 14, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Phantom Limb Pain
Device: mirror-box treatment
Behavioral: observation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study Using Functional MRI to Examine Changes in the Brain in Unilateral Lower Limb Amputees Treated With Mirror Therapy for Phantom Limb Pain.

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • The identification of brain regions activated before and after treatment with mirror therapy. [ Time Frame: 0, 2, and 4 weeks ] [ Designated as safety issue: No ]
  • phantom limb pain as measured using the VAS and McGill [ Time Frame: daily for 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
12 non-amputee control subjects will be scanned at 0, 2 and 4 weeks but will not recieve mirror therapy.
Behavioral: observation
observation
Experimental: 2
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
15 minutes daily for 4 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For Amputee Subjects:

  • Male or female subjects
  • 18 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
  • Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into study.
  • Ability to follow study instructions and likely to complete all required visits

For Control Subjects:

  • Male or female subjects
  • 18 to 75 years of age
  • Written informed consent and written authorization for use or release of health and research study information
  • Right-handed.
  • No prior history of vertebral disk disease/condition
  • Sciatica
  • Radiculopathy
  • Normal neurological examination
  • Ability to follow study instructions and likely to complete all required visits

Exclusion Criteria:

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
  • Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering

For Control Subjects:

  • Age less than 18 or greater than 75 years
  • Presence of an amputation
  • 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 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662415

Contacts
Contact: Jack W Tsao, MD (301) 295-9684 tsaoj@grc.nia.nih.gov
Contact: Christopher Baker, PhD (301) 435-6058

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Jack W Tsao, MD    301-295-9684    tsaoj@grc.nia.nih.gov   
United States, Maryland
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20892
Contact: Christopher Baker, PhD    301-435-6058      
Sponsors and Collaborators
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00662415     History of Changes
Other Study ID Numbers: DCI-0771043
Study First Received: March 14, 2008
Last Updated: April 14, 2008
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
phantom limb pain
fMRI
mirror therapy

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 18, 2014