Mirror Therapy for Phantom Limb Pain

NCT00623818 | Completed

• 2 other identifiers: 08005208-M-0052
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This study, conducted at the National Institutes of Health (NIH) and at Walter Reed Army Medical Center (WRAMC), will explore the phenomenon of phantom limb pain (a continued feeling of pain in an amputated limb) and will use functional magnetic resonance imaging (fMRI) to investigate the effect of mirror therapy on phantom limb pain. Right-handed people between 18 and 75 years of age who are in the WRAMC Military Amputee Research Program and healthy control subjects may be eligible for this study. Participants undergo the following procedures: Amputees

• Questionnaires to assess strength of handedness and footedness and pain perception.
• Mirror therapy for phantom limb pain five times a week for 4 weeks in 15-minute sessions.
• MRI and fMRI scans before starting mirror therapy, after 2 weeks of therapy and after 4 weeks of therapy. MRI uses a magnetic field and radio waves to image brain tissue. The subject lies on a table that can slide in and out of the scanner (a metal cylinder). The structural MRI scan lasts about 30 minutes. For fMRI, the subject performs tasks while in the scanner in order to show changes in brain activity involved in performing those tasks. Subjects are shown pictures of feet and other body parts, are asked to move their feet, and receive tactile (touch) stimulation of the foot or other body parts. Control Subjects One group of control subjects undergoes a single fMRI procedure. A second group of control subjects undergoes the same sequence of three fMRIs over the same time period as the amputee subjects. None of the control subjects undergo mirror therapy. ...

Conditions

Amputation

Keywords

Mirror Therapy; Phantom Limb Pain; Amputee; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Changes in fMRI signal

Secondary Outcomes (1)

• Changes in pain measures

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For amputee subjects with PLP:
• 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
• Unilateral limb amputation
• Any level of prosthetic experience
• No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
• No evidence of traumatic brain injury (TBI - permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness)
• No known neurological disease or brain damage
• No neurological condition that would 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 amputee subjects without PLP:
• 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

You may not qualify if:

• For amputee subjects with PLP:
• Age less than 18 or greater than 75 years.
• Multiple limb amputation
• Amputation due to diabetes or vascular claudication
• Pending revision surgeries.
• Presence of embedded metallic shrapnel or other metal not compatible with MRIscanning.
• Presence of traumatic brain injury
• 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.
• Current 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.
• Positive pregnancy test at the time of scanning (within 24 hours prior to the scheduled MRI scan, female subjects of child-bearing age will be given a pregnancy test)
• For amputee subjects without PLP:
• Age less than 18 or greater than 75 years.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20301, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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: 9762952 BACKGROUND

• 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: 6709380 BACKGROUND

• 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: 6657285 BACKGROUND

• 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: 28850360 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Christopher I Baker, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: February 26, 2008
• Study Start: March 5, 2008
• Study Completion: December 10, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12-10

Locations

US (2)