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

January 14, 2014 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan
        • Recruiting
        • NTUH department of orthopedics; NTU department of electrical engneering
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Amputees / healthy subjects

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • with mental diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amputees
Amputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site
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
exposure 40-minute far infrared ray to the sole for each person/amputee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Rong-Sen Yang, Department of orthopedics, NTUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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