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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01936558
First received: May 1, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention
Exposure to Infrared Radiation
Other: Far infrared ray to the sole

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Target Follow-Up Duration: 6 Months
Official Title: The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Resting functional MR images [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01936558     History of Changes
Other Study ID Numbers: 201210078RIC
Study First Received: May 1, 2013
Last Updated: January 14, 2014
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on November 20, 2014