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Cutaneous Denervation in Alcoholic Neuropathy

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 September 2005 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190073
First Posted: September 19, 2005
Last Update Posted: September 19, 2005
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:
Far Eastern Memorial Hospital
  Purpose
Peripheral neuropathy is a frequent neurological complication of chronic alcoholism. Most studies evaluated large-fiber involvement by nerve conduction studies (NCS). Since previous studies document the predominant injury of small myelinated and unmyelinated fibers in patients with alcoholic neuropathy, it will be imperative to know their prevalence and clinical significance. Moreover, the pathogenesis of alcoholic neuropathy, especially the roles of ethanol and its metabolites and thiamine, remains elusive. This proposal will be designed to understand the extent and clinical significance of cutaneous nerve degeneration in the skin of alcoholic patients and to investigate its pathogenesis. We will investigate cutaneous innervation by 3 mm punch skin biopsies with immunohistochemistry for protein gene product 9.5 and quantifying epidermal nerve density (END) in alcoholic patients. Patients will undergo clinical evaluation, quantitative sensory testing (QST), nerve conduction studies (NCS), and tests of sympathetic skin response (SSR) and beat-to-beat RR interval variability (RRIV). The prevalence of peripheral neuropathy in chronic alcoholic patients with emphasis on small-fiber involvement will be first evaluated. The sensitivity of punch skin biopsy, QST, SSR and RRIV tests, and NCS will be compared, and the correlations between END and psychophysic and electrodiagnostic parameters will be discussed. Subsequently, we will elucidate the clinical significance of END reduction in alcoholic patients. Patients with evidences of involvement of central nervous system will be excluded, and END will be correlated with clinical manifestations and neurological deficits. Finally, the role of ethanol and thiamine in alcoholic neuropathy will be further studied. To clarify the role of thiamine in alcoholic neuropathy, we will examine whether it has influences on small-fiber degeneration. This may provide important information in understanding the pathogenesis and designing optimal treatment for alcoholic neuropathy.

Condition
Alcohol Abuse Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Cutaneous Denervation in Alcoholic Neuropathy

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 30
Study Start Date: January 2005
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- The inclusion criteria include daily uptake of at least 100 g ethanol for more than 3 years prior to the onset of neuropathic symptoms

Exclusion Criteria:

- Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics, were excluded.

  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): NCT00190073


Contacts
Contact: Ming-Tsung Tseng, MD 886-2-89667000 ext 4656 mingtsungtseng@yahoo.com.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 22056
Contact: Ming-Tsung Ming-Tsung Tseng, MD    886-2-89667000 ext 4656    mingtsungtseng@yahoo.com.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Director: Ming-Tsung Tseng, MD 21,Nan-Yas S. Road. Sec 2 Pan-Chiao, Taipei, Taiwan
Study Director: Sung-Tsang Hsieh, MD, PhD Department of Anatomy and Cell Biology, National Taiwan University College of Medicine, 1 Jen-Ai Road., Taipei 100, Taiwan
  More Information

ClinicalTrials.gov Identifier: NCT00190073     History of Changes
Other Study ID Numbers: FEMH-94003
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: September 19, 2005
Last Verified: September 2005

Keywords provided by Far Eastern Memorial Hospital:
Epidermal nerves;protein gene product 9.5; ethanol

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Alcoholism
Alcoholic Neuropathy
Neuromuscular Diseases
Nervous System Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Polyneuropathies
Alcohol-Induced Disorders, Nervous System
Neurotoxicity Syndromes
Poisoning
Alcohol-Induced Disorders