Recruiting

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

Sponsor:

United States Department of Defense

Code:

NCT00662415

Conditions

Phantom Limb Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

mirror-box treatment

observation

Study Details

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.

Conditions

Phantom Limb Pain

Study ID

NCT00662415

Start date

Feb, 2008

Status verified date

Apr, 2008

Completion date

Feb, 2010

Anticipated

Primary completion date

Feb, 2010

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: 1

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

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.

Interventions

mirror-box treatment

15 minutes daily for 4 weeks

observation

Primary outcome measure

The identification of brain regions activated before and after treatment with mirror therapy. [ Time Frame: 0, 2, and 4 weeks ]
phantom limb pain as measured using the VAS and McGill [ Time Frame: daily for 4 weeks ]

Central Contacts and Locations

Central contacts

Jack W Tsao, MD

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

Christopher Baker, PhD

(301) 435-6058

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20307

Contacts

Jack W Tsao, MD

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

National Institutes of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Christopher Baker, PhD

301-435-6058

More Information

Sponsor

United States Department of Defense

Last update posted

Apr 21, 2008

Last verified

Apr, 2008

Keywords

phantom limb pain
fMRI
mirror therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Department of Defense on 2008-04-21.