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Sponsored by: |
Far Eastern Memorial Hospital |
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Information provided by: | Far Eastern Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00190073 |
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 |
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Alcohol Abuse Peripheral Neuropathy |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Case Control, Retrospective Study |
Official Title: | Cutaneous Denervation in Alcoholic Neuropathy |
Estimated Enrollment: | 30 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contact: Ming-Tsung Tseng, MD | 886-2-89667000 ext 4656 | mingtsungtseng@yahoo.com.tw |
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 |
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 |
Study ID Numbers: | FEMH-94003, FEMH-94003 |
Study First Received: | September 11, 2005 |
Last Updated: | September 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00190073 History of Changes |
Health Authority: | Taiwan: Department of Health |
Epidermal nerves;protein gene product 9.5; ethanol |
Alcohol-Induced Disorders Neurotoxicity Syndromes Alcoholic Neuropathy Polyneuropathies Poisoning Disorders of Environmental Origin Neuromuscular Diseases |
Mental Disorders Peripheral Nervous System Diseases Alcoholism Substance-Related Disorders Alcohol-Related Disorders Ethanol |
Alcohol-Induced Disorders Neurotoxicity Syndromes Alcoholic Neuropathy Nervous System Diseases Polyneuropathies Poisoning Disorders of Environmental Origin |
Alcohol-Induced Disorders, Nervous System Neuromuscular Diseases Mental Disorders Peripheral Nervous System Diseases Alcoholism Substance-Related Disorders Alcohol-Related Disorders |