Neuropathic PainNCT00789347
Analysis of Cortical Excitability in Neuropathic Pain
An observational study of Neuropathic Pain and Cortical Excitability, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Cortical Excitability
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2008to Oct 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic healthy volunteer
Who may be able to join
- Healthy volunteers
- patients with pain resulted from dysfunction of peripheral or central nervous system
- the disorders of peripheral nerves are diagnosed by nerve conduction study, quantitative sensory test, quantification of skin innervation or contact heat evoked potentials
- lesion of central nervous system should be confirmed by neuroimage.
Who cannot join
- previous history of epilepsy, seizure disorders or major head injury
- previous brain surgery or intracranial metalic implant
- implanted devices as cardiac pacemaker
- pregnant subjects
- patient with severe cardiac or pulmonary disease who potentially cannot tolerate stress
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ming-Kai Pan, M.D., 886-2-23123456 ext. 9803397, emorypan@gmail.com
Chi-Chao Chao, M.D., 886-2-23123456 ext. 9801967, ccchao@ntu.edu.tw
About this study
Official title: Analysis of Cortical Excitability in Neuropathic Pain: an Electrophysiology Study.
The purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections.
Read the detailed description
There are several brain areas responsible for neuropathic pain reported in functional image studies, including primary sensory cortex, insula, and anterior cingulate gyrus. However, it is few informations about the functional status of these areas. Besides, the reason of the individual variability about the developement of neuropathic pain remains unknown. It is lack of satisfactory explanation about why some people developed neuropathic pain in certain diseased situation (for example, type 2 diabetes), while others do not.
We hypothesis that patients with neuropathic pain has abnormal cortical excitability and plasticity in certain brain area. Therefore developed neuropathic pain certain diseased condition while others not. Therefore, we will use multimodal electrophysiology tools,such as transcranial magnetic stimulation, peripheral nerve stimulation, and contact heat evoke potential to monitor the cortical excitability and plasticity non-invasively.
- Conditions
- Neuropathic Pain, Cortical Excitability
- Keywords
- Neuropathic pain, Cortical excitability, Transcranial magnetic stimulation, Contact Heat evoked potential, peripheral nerve stimulation, neurotrophic factors
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers | |
| 2 | Patient with neuropathic pain | |
| 3 | patients without neuropathic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal cortical excitability in motor-sensory cross-talk
Measured: non-applicable
Secondary outcomes (1)
Genetic variability of neurotrophic factors between groups
Measured: non-applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Kai Pan, M.D., Study director, National Taiwan University Hospital, Department of NeurologyChi-Chao Chao, M.D., Study director, National Taiwan University Hospital, Department of NeurologySung-Tsang Hsieh, M.D. PhD, Principal investigator, National Taiwan University Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789347
- Sponsor's protocol ID
- 200806061R
- Status last verified
- Mar 2010
- First submitted
- 10 Nov 2008
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cortical Excitability in Neuropathic Pain: an Electrophysiology Study.
- ClinicalTrials.gov ID
- NCT00789347
- Acronym / sponsor ID
- 200806061R
- Conditions
- Neuropathic Pain, Cortical Excitability
- Keywords
- Neuropathic pain, Cortical excitability, Transcranial magnetic stimulation, Contact Heat evoked potential, peripheral nerve stimulation, neurotrophic factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 11 Nov 2008 (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.
The purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections.
Detailed description
There are several brain areas responsible for neuropathic pain reported in functional image studies, including primary sensory cortex, insula, and anterior cingulate gyrus. However, it is few informations about the functional status of these areas. Besides, the reason of the individual variability about the developement of neuropathic pain remains unknown. It is lack of satisfactory explanation about why some people developed neuropathic pain in certain diseased situation (for example, type 2 diabetes), while others do not.
We hypothesis that patients with neuropathic pain has abnormal cortical excitability and plasticity in certain brain area. Therefore developed neuropathic pain certain diseased condition while others not. Therefore, we will use multimodal electrophysiology tools,such as transcranial magnetic stimulation, peripheral nerve stimulation, and contact heat evoke potential to monitor the cortical excitability and plasticity non-invasively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy volunteers |
| 2 | – | –Patient with neuropathic pain |
| 3 | – | –patients without neuropathic pain |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic healthy volunteer
Key inclusion criteria (4 listed)
- Healthy volunteers
- patients with pain resulted from dysfunction of peripheral or central nervous system
- the disorders of peripheral nerves are diagnosed by nerve conduction study, quantitative sensory test, quantification of skin innervation or contact heat evoked potentials
- lesion of central nervous system should be confirmed by neuroimage.
Key exclusion criteria (5 listed)
- previous history of epilepsy, seizure disorders or major head injury
- previous brain surgery or intracranial metalic implant
- implanted devices as cardiac pacemaker
- pregnant subjects
- patient with severe cardiac or pulmonary disease who potentially cannot tolerate stress
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
Abnormal cortical excitability in motor-sensory cross-talk
Time frame: non-applicable
1 secondary outcome
Genetic variability of neurotrophic factors between groups
Time frame: non-applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
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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.
Ming-Kai Pan, M.D. study director
National Taiwan University Hospital, Department of Neurology
Chi-Chao Chao, M.D. study director
National Taiwan University Hospital, Department of Neurology
Sung-Tsang Hsieh, M.D. PhD principal investigator
National Taiwan University Hospital, Department of Neurology
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 Neuropathic Pain and Cortical Excitability, 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 4 inclusion and 5 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 2 Apr 2010. 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 Ming-Kai Pan, M.D. (886-2-23123456 ext. 9803397, emorypan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal cortical excitability in motor-sensory cross-talk (time frame: non-applicable). 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 2 Apr 2010.