Peripheral Nerve DiseasesNCT00173420
Mechanisms of Neuropathic Pain: Investigation by Contact Heat Evoked Potential
An observational study of Peripheral Nerve Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In order to clarify the normal components of thermal and painful evoked potentials by heat in normal subjects of both genders and different age group, to clarify the effect of specific anatomy in pain transduction, transmission and modification, and to establish the effect of peripheral nerve and their terminal free… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Diseases
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to not given
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with peripheral nerve diseases or other neurological diseased with sensory disturbance
- Normal subjects without:
- Systemic disease like diabetes mellitus, renal disease or other systemic diseases
- Abnormal neurological symptoms or signs
- Psychological disease like affective disorders or psychosis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anatomy and Cell Biology, National Taiwan University College of Medicine
Taipei
Sung-Tsang Hsieh, PhD, 886-2-23123456 ext. 8182, sthsieh@ha.mc.ntu.edu.tw
About this study
In order to clarify the normal components of thermal and painful evoked potentials by heat in normal subjects of both genders and different age group, to clarify the effect of specific anatomy in pain transduction, transmission and modification, and to establish the effect of peripheral nerve and their terminal free ending on the nociceptive transduction, the investigators will use heat stimulation on normal controls and patients with neurological diseases to clarify such issues.
Read the detailed description
Only a few studies focus on clinical diseases like neuropathic pain or neurogenic pain. Little is known about the differences between normal and pathogenic pain processing. It is an opportunity to apply EEG, ERPs in the clinical fields. In many clinical conditions, brain lesions provide a chance to study the possible roles of one neural structure in pain integration and processing. In addition the applications of EEG/ERPs on clinical conditions may be help in the understanding about mechanism and genesis of pain in pathogenic conditions, the diagnosis of pathogenic pain, and the therapeutic aspects of these abnormal pain senses.
One limit in the study of human pain is the inappropriate stimulation method. Evoked potentials by contact heat have previously been difficult to elicit due to slow temperature rise times associated with thermal stimulators. However recently, the CHEPS (Contact Heat-Evoked Potential Stimulator) is developed, which uses a newly developed heat-foil technology and can create a rapid heating rate (up to 70°C/sec). The baseline and peak temperature and the rising time can be precisely controlled. It provides a non-invasive technique in the investigation of human pain activation related to thermal and nociceptive pathways involved in pain processing. Unlike the heat stimulation delivered by laser, CHEPS can deliver noxious thermal stimuli repeatedly to a large area of skin to evoke a pain response of A-Delta and C fibers. In addition the rate of stimulation can be rapid to lead to the effect of temporal summation. When used with an EEG recording system, a patient's responses to pain perception and evoked potentials (EPs) can be recorded, which provide objective information about integrity of the nociceptive afferents of peripheral nerve system, spinal cord, as well as the brain response of different structures. The CHEPS provide the investigators a practical and convenient tool in clinical application to study pain. The investigators will use the CHEPS as stimulation for studying the heat evoked potentials and analyze the difference between the normal subjects and patients with peripheral nerve diseases. These might help to clarify the mechanism of neuropathic pain.
- Conditions
- Peripheral Nerve Diseases
- Keywords
- Normal Controls
- Medical subject headings
- Peripheral Nervous System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve DiseasesStudies 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
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung-Tsang Hsieh, PhD, Study director, Department of Anatomy and Cell Biology, National Taiwan University College of Medicine; Department of Neurology, National Taiwan University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173420
- Sponsor's protocol ID
- 9461700654
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 23 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Neuropathic Pain: Investigation by Contact Heat Evoked Potential
- ClinicalTrials.gov ID
- NCT00173420
- Acronym / sponsor ID
- 9461700654
- Conditions
- Peripheral Nerve Diseases
- Keywords
- Normal Controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 15 Sep 2005 (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.
In order to clarify the normal components of thermal and painful evoked potentials by heat in normal subjects of both genders and different age group, to clarify the effect of specific anatomy in pain transduction, transmission and modification, and to establish the effect of peripheral nerve and their terminal free ending on the nociceptive transduction, the investigators will use heat stimulation on normal controls and patients with neurological diseases to clarify such issues.
Detailed description
Only a few studies focus on clinical diseases like neuropathic pain or neurogenic pain. Little is known about the differences between normal and pathogenic pain processing. It is an opportunity to apply EEG, ERPs in the clinical fields. In many clinical conditions, brain lesions provide a chance to study the possible roles of one neural structure in pain integration and processing. In addition the applications of EEG/ERPs on clinical conditions may be help in the understanding about mechanism and genesis of pain in pathogenic conditions, the diagnosis of pathogenic pain, and the therapeutic aspects of these abnormal pain senses.
One limit in the study of human pain is the inappropriate stimulation method. Evoked potentials by contact heat have previously been difficult to elicit due to slow temperature rise times associated with thermal stimulators. However recently, the CHEPS (Contact Heat-Evoked Potential Stimulator) is developed, which uses a newly developed heat-foil technology and can create a rapid heating rate (up to 70°C/sec). The baseline and peak temperature and the rising time can be precisely controlled. It provides a non-invasive technique in the investigation of human pain activation related to thermal and nociceptive pathways involved in pain processing. Unlike the heat stimulation delivered by laser, CHEPS can deliver noxious thermal stimuli repeatedly to a large area of skin to evoke a pain response of A-Delta and C fibers. In addition the rate of stimulation can be rapid to lead to the effect of temporal summation. When used with an EEG recording system, a patient's responses to pain perception and evoked potentials (EPs) can be recorded, which provide objective information about integrity of the nociceptive afferents of peripheral nerve system, spinal cord, as well as the brain response of different structures. The CHEPS provide the investigators a practical and convenient tool in clinical application to study pain. The investigators will use the CHEPS as stimulation for studying the heat evoked potentials and analyze the difference between the normal subjects and patients with peripheral nerve diseases. These might help to clarify the mechanism of neuropathic pain.
Study design
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with peripheral nerve diseases or other neurological diseased with sensory disturbance
- Normal subjects without:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
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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.
Sung-Tsang Hsieh, PhD study director
Department of Anatomy and Cell Biology, National Taiwan University College of Medicine; Department of Neurology, National Taiwan University Hospital.
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 Peripheral Nerve Diseases, 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 5 inclusion and 0 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 23 Oct 2007. 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 Sung-Tsang Hsieh, PhD (886-2-23123456 ext. 8182, sthsieh@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 23 Oct 2007; AzTrials last refreshed its copy on 8 Nov 2026.