Exposure to Infrared RadiationNCT01936558
The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
An observational study of Exposure to Infrared Radiation, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure to Infrared Radiation
- What is being tested?
- Far infrared ray to the sole
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Amputees / healthy subjects
Who may be able to join
- Amputees: at least one arm or one leg amputated
- Healthy subjects: healthy person under 30 years old
Who cannot join
- with mental diseases
Trial locations and contacts
1 site in 1 country.
Chi-Yu Huang contact
Taiwan1 site, 1 recruiting
- Recruiting
NTUH department of orthopedics; NTU department of electrical engneering
Taipei, Taiwan
ChiYu Huang, chiyuhuang@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Exposure to Infrared Radiation
- Being tested
- Far infrared ray to the sole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far infrared ray to the soleOther
exposure 40-minute far infrared ray to the sole for each person/amputee.
| Study group | Role | What they receive |
|---|---|---|
| Amputees | Amputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site Receives: Other: Far infrared ray to the sole | |
| Healthy subjects | Healthy subjects under 30 years old/ Far infrared ray to the sole Receives: Other: Far infrared ray to the sole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Infrared RadiationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong-Sen Yang, Study chair, Department of orthopedics, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936558
- Sponsor's protocol ID
- 201210078RIC
- Status last verified
- Jan 2014
- First submitted
- 1 May 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
- ClinicalTrials.gov ID
- NCT01936558
- Acronym / sponsor ID
- 201210078RIC
- Conditions
- Exposure to Infrared Radiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amputees | – | Other: Far infrared ray to the soleAmputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site |
| Healthy subjects | – | Other: Far infrared ray to the soleHealthy subjects under 30 years old/ Far infrared ray to the sole |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Amputees / healthy subjects
Key inclusion criteria (2 listed)
- Amputees: at least one arm or one leg amputated
- Healthy subjects: healthy person under 30 years old
Key exclusion criteria (1 listed)
- with mental diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far infrared ray to the soleexposure 40-minute far infrared ray to the sole for each person/amputee. | Other | Amputees, Healthy subjects |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Yu Huang contact
Rong-Sen Yang study chair
Department of orthopedics, NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Infrared Radiation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Yu Huang (chiyuhuang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting functional MR images (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.