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

Exposure to Infrared Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01936558
• Other study ID #: 201210078RIC
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2013
• Last updated: January 14, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: National Taiwan University Hospital
• Contact: Chi-Yu Huang
• Email: chiyuhuang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Exposure to Infrared Radiation
• Phantom Limb

Intervention

Other:
• Far infrared ray to the sole
exposure 40-minute far infrared ray to the sole for each person/amputee.

Locations

Country	Name	City	State
Taiwan	NTUH department of orthopedics; NTU department of electrical engneering	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting functional MR images	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	No