- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936558
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
Conditions
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
-
-
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Taipei, Taiwan
- Recruiting
- NTUH department of orthopedics; NTU department of electrical engneering
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Contact:
- ChiYu Huang
- Email: chiyuhuang@ntu.edu.tw
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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
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201210078RIC
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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