AmputationNCT00623818
Mirror Therapy for Phantom Limb Pain
An observational study of Amputation, run by National Institute of Mental Health (NIMH) at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2008to 10 Dec 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 29Show fewer
- 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
- 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
- No recurring episodes of PLP
- Ability to follow study instructions and likely to complete all required visits.
- For healthy 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.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Normal neurological examination.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- 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.
Show all 35Show fewer
- 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.
- Multiple limb amputation.
- Amputation due to diabetes or vascular claudication
- Pending revision surgeries.
- Presence of embedded metallic shrapnel or other metal not compatible with MRI scanning.
- 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 healthy 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
- 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
- Current Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20301
About this study
Official title: fMRI Investigation of Cortical Reorganization and Phantom Limb Pain Following Amputation
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:
Read more
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.
...
Read the detailed description
Objective: The aim of this study is to investigate phantom limb pain (PLP), cortical reorganization and the modulation of PLP by visual input. Mirror therapy (viewing the intact limb in a mirror so that it appears to be the missing limb) has been shown to reduce PLP. This reduction demonstrates that vision can play a key role in modulating PLP. The study proposed here will identify brain regions critical for the success of this therapy using functional magnetic resonance imaging (fMRI).
Study population: Individuals with unilateral amputation of individual limbs and at least three episodes of PLP a week. Additionally, we will study amputees without PLP and healthy control volunteer subjects with no limb amputations.
Design: Amputee subjects with PLP will be scanned using fMRI while they undergo mirror therapy for PLP. During fMRI scans subjects will see images of hands or feet, move their limbs or experience tactile stimulation. Mirror therapy requires four weeks to be effective. Amputee subjects will be scanned prior to starting therapy, two weeks after starting mirror therapy and again after four weeks of mirror therapy. Mirror therapy sessions will be conducted daily and subjects will also complete daily questionnaires (Visual Analogue Scale, or VAS, and Short-Form McGill Pain Questionnaire or SF-MPQ) assessing their level of pain and number of PLP episodes. Amputees without PLP and one group of healthy control subjects will go through the same series of functional imaging scans over the same time period as the amputee subjects, allowing us to identify brain changes that may be associated with repeated scanning (e.g. due to practice of tasks) rather than resulting from the mirror therapy. Another group of control subjects will be scanned once to identify particular brain regions that might be involved in the integration of visual, motor and somatosensory information for use in the analysis of the amputee subject data.
Outcome measures: Changes in fMRI activation during the course of mirror therapy will be compared with data on the number of episodes of PLP, the average length of episodes, and the average intensity of pain assessed using the VAS and SF-MPQ. Analyses will focus on cortical regions known to be involved in visual, tactile and motor representations (including primary motor cortex, primary and secondary somatosensory cortex and regions of visual cortex selectively responsive during the viewing of body parts). Additional brain regions that might be involved in integrating visual, motor and somatosensory information will be identified in control subjects. Direct comparisons will be made between cortical regions (e.g. somatosensory regions) involved in the representation of the amputated limb compared with the intact limb and between amputee subject data and control subject data.
- Conditions
- Amputation
- Keywords
- Mirror Therapy, Phantom Limb Pain, Amputee, Healthy Volunteer, HV
- Medical subject headings
- Phantom Limb
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fMRI signal
Secondary outcomes (1)
Changes in pain measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study start5 Mar 2008
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher I Baker, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623818
- Sponsor's protocol ID
- 080052
- Other IDs
- 08-M-0052
- Status last verified
- 10 Dec 2019
- First submitted
- 24 Feb 2008
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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.
PubMed 9762952Sherman 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.
PubMed 6709380Jensen 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.
PubMed 6657285Griffin 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.
PubMed 28850360
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Investigation of Cortical Reorganization and Phantom Limb Pain Following Amputation
- ClinicalTrials.gov ID
- NCT00623818
- Acronym / sponsor ID
- 080052
- Conditions
- Amputation
- Keywords
- Mirror Therapy, Phantom Limb Pain, Amputee, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Mar 2008
- Study completion
- 10 Dec 2019
- First posted
- 26 Feb 2008 (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.
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.
...
Detailed description
Objective: The aim of this study is to investigate phantom limb pain (PLP), cortical reorganization and the modulation of PLP by visual input. Mirror therapy (viewing the intact limb in a mirror so that it appears to be the missing limb) has been shown to reduce PLP. This reduction demonstrates that vision can play a key role in modulating PLP. The study proposed here will identify brain regions critical for the success of this therapy using functional magnetic resonance imaging (fMRI).
Study population: Individuals with unilateral amputation of individual limbs and at least three episodes of PLP a week. Additionally, we will study amputees without PLP and healthy control volunteer subjects with no limb amputations.
Design: Amputee subjects with PLP will be scanned using fMRI while they undergo mirror therapy for PLP. During fMRI scans subjects will see images of hands or feet, move their limbs or experience tactile stimulation. Mirror therapy requires four weeks to be effective. Amputee subjects will be scanned prior to starting therapy, two weeks after starting mirror therapy and again after four weeks of mirror therapy. Mirror therapy sessions will be conducted daily and subjects will also complete daily questionnaires (Visual Analogue Scale, or VAS, and Short-Form McGill Pain Questionnaire or SF-MPQ) assessing their level of pain and number of PLP episodes. Amputees without PLP and one group of healthy control subjects will go through the same series of functional imaging scans over the same time period as the amputee subjects, allowing us to identify brain changes that may be associated with repeated scanning (e.g. due to practice of tasks) rather than resulting from the mirror therapy. Another group of control subjects will be scanned once to identify particular brain regions that might be involved in the integration of visual, motor and somatosensory information for use in the analysis of the amputee subject data.
Outcome measures: Changes in fMRI activation during the course of mirror therapy will be compared with data on the number of episodes of PLP, the average length of episodes, and the average intensity of pain assessed using the VAS and SF-MPQ. Analyses will focus on cortical regions known to be involved in visual, tactile and motor representations (including primary motor cortex, primary and secondary somatosensory cortex and regions of visual cortex selectively responsive during the viewing of body parts). Additional brain regions that might be involved in integrating visual, motor and somatosensory information will be identified in control subjects. Direct comparisons will be made between cortical regions (e.g. somatosensory regions) involved in the representation of the amputated limb compared with the intact limb and between amputee subject data and control subject data.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (35 listed)
- 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.
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
Changes in fMRI signal
1 secondary outcome
Changes in pain measures
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 17 Dec 2019.
- 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 6709380Sherman 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.
- Background: PubMed 6657285Jensen 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.
- Derived from this study: PubMed 28850360Griffin 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.
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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.
Christopher I Baker, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by National Institute of Mental Health (NIMH) at 2 sites 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 29 inclusion and 35 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes in fMRI signal. 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 NCT00623818, which also lists 4 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 17 Dec 2019.