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The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees

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ClinicalTrials.gov Identifier: NCT01936558
Recruitment Status : Unknown
Verified January 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2013
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response.

Condition or disease Intervention/treatment
Exposure to Infrared Radiation Other: Far infrared ray to the sole

Detailed Description:
This project will investigate two main hypotheses based on our previous studies on phantom limb sensation and phantom limb pain. The first hypothesis states that phantom limb sensation and phantom limb pain both correlate with the 'phantom limb', while the second one maintains that the phantom limb can interact with the patient's body by means of the meridian system. With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response. By analyzing the data collected from both groups, the investigators expect both hypotheses will be supported by the results of experiments in this project.

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case Control
Target Follow-Up Duration: 6 Months
Official Title: The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
Study Start Date : January 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Amputees
Amputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site
Other: Far infrared ray to the sole
exposure 40-minute far infrared ray to the sole for each person/amputee.
Healthy subjects
Healthy subjects under 30 years old/ Far infrared ray to the sole
Other: Far infrared ray to the sole
exposure 40-minute far infrared ray to the sole for each person/amputee.


Outcome Measures

Primary Outcome Measures :
  1. Resting functional MR images [ Time Frame: one year ]
    The resting fMRI images will be obtained before and after the far infrared exposed to the phantom limb site. The default mode of the brain will be analyzed. If the default mode was changed, it was one of the evidence that the neural signal was transmitted from the phantom limb site into the brain and caused the change.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Amputees / healthy subjects
Criteria

Inclusion Criteria:

  • Amputees: at least one arm or one leg amputated
  • Healthy subjects: healthy person under 30 years old

Exclusion Criteria:

  • with mental diseases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936558


Contacts
Contact: Chi-Yu Huang chiyuhuang@ntu.edu.tw

Locations
Taiwan
NTUH department of orthopedics; NTU department of electrical engneering Recruiting
Taipei, Taiwan
Contact: ChiYu Huang       chiyuhuang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Rong-Sen Yang Department of orthopedics, NTUH
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01936558     History of Changes
Other Study ID Numbers: 201210078RIC
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

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