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Analysis of Cortical Excitability in Neuropathic Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789347
First Posted: November 11, 2008
Last Update Posted: April 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections.

Condition
Neuropathic Pain Cortical Excitability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Analysis of Cortical Excitability in Neuropathic Pain: an Electrophysiology Study.

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Abnormal cortical excitability in motor-sensory cross-talk [ Time Frame: non-applicable ]

Secondary Outcome Measures:
  • Genetic variability of neurotrophic factors between groups [ Time Frame: non-applicable ]

Biospecimen Retention:   Samples With DNA
Genomic polymorphism of neurotrophic factors.

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy volunteers
2
Patient with neuropathic pain
3
patients without neuropathic pain

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic healthy volunteer
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789347


Contacts
Contact: Ming-Kai Pan, M.D. 886-2-23123456 ext 9803397 emorypan@gmail.com
Contact: Ch-Chao Chao, M.D. 886-2-23123456 ext 9801967 ccchao@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ming-Kai Pan, M.D.    886-2-23123456 ext 9803397    emorypan@gmail.com   
Contact: Chi-Chao Chao, M.D.    886-2-23123456 ext 9801967    ccchao@ntu.edu.tw   
Sub-Investigator: Ming-Kai Pan, M.D.         
Principal Investigator: Sung-Tsang Hsieh, M.D. PhD         
Sub-Investigator: Chi-Chao Chao, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ming-Kai Pan, M.D. National Taiwan University Hospital, Department of Neurology
Study Director: Chi-Chao Chao, M.D. National Taiwan University Hospital, Department of Neurology
Principal Investigator: Sung-Tsang Hsieh, M.D. PhD National Taiwan University Hospital, Department of Neurology
  More Information

Responsible Party: Sung-Tsang Hsieh/ MD. PHD., National Taiwan University, Department of Neurology
ClinicalTrials.gov Identifier: NCT00789347     History of Changes
Other Study ID Numbers: 200806061R
First Submitted: November 10, 2008
First Posted: November 11, 2008
Last Update Posted: April 2, 2010
Last Verified: March 2010

Keywords provided by National Taiwan University Hospital:
Neuropathic pain
Cortical excitability
Transcranial magnetic stimulation
Contact Heat evoked potential
peripheral nerve stimulation
neurotrophic factors

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms