Effect of Alcohol on Tremors
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|ClinicalTrials.gov Identifier: NCT00001925|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||November 3, 1999|
|First Posted Date ICMJE||November 4, 1999|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||January 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001925 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Alcohol on Tremors|
|Official Title ICMJE||Effect of Alcohol on Physiologic and Pathologic Tremors|
Tremors are involuntary movements of a part or parts of the body that occur because of alternating contraction and relaxation of muscles. The causes behind most tremors are poorly understood.
Some studies suggest tremors could be caused by abnormalities in a particular area of the brain called the olivary nucleus. Researchers believe that the cells making up the olivary nucleus may be responsible for generating a central rhythm of the body and may therefore also be responsible for the generation of tremors.
Consumption of alcohol has been known to reduce tremors in some patients. Researchers believe that the alcohol may work directly on the cells of the olivary nucleus. As a result, researchers would like to determine the effects of alcohol on three different kinds of tremors (physiological, symptomatic palatal, and essential palatal).
|Detailed Description||The pathophysiology and anatomical basis of most tremors remains poorly understood. One particular theory of essential tremor, the olivary hypothesis, has gained support from various studies. These studies point to the olivary nucleus as possible central rhythm generator. Cells in the olivary nucleus show spontaneous rhythmic discharges that can be suppressed by alcohol. Since alcohol is known to suppress tremor in some patients with essential tremor, one can theorize that it is through its effect on the olivary nucleus; that is, the inferior olive is the generator of the tremor. Given this assumption, we intend to study the effect of alcohol on three different kinds of tremor: the 8-12 Hz component of physiological tremor, symptomatic palatal tremor and essential palatal tremor. Our hypothesis is that the central generator of each of these types of tremor lies in the inferior olive and that the ingestion of alcohol should reduce the amplitude of the tremor, similar to the effect of alcohol seen in essential tremor.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Alcohol|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||July 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A total of 20 subjects will be enrolled in the study. 10 normal subjects will be enrolled in the study. All will have an 8-12 Hz component of physiologic tremor as determined by neurophysiologic studies. Patients will have a prominent 8-12 Hz spike on accelerometry recordings that is associated with an EMG spike at the same frequency.
5 patients with essential palatal tremor and 5 patients with symptomatic palatal tremor will be included.
All participants must be a minimum of 21 years of age.
The presence of any medical condition, such as liver disease, history or family history of alcoholism, that can reasonably be expected to subject the patient to unwarranted risk or compromise the value of the data.
Any patient with pathologic tremor, such as parkinsonian rest tremor, essential tremor, or tremor secondary to medications or structural brain lesions.
Any clinically significant laboratory abnormalities.
Lack of effective contraception.
Patients who are pregnant.
Inability to understand the nature of the study or its procedures.
Persons under the age of 21, who are not of legal age to consume alcohol in Maryland.
Patients taking any psychoactive medications including certain cough or cold medicine preparations.
No one will be excluded or discriminated against based on the grounds of race, creed, gender, color, or national origin. Every attempt will be made to include women and minorities in the study population.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001925|
|Other Study ID Numbers ICMJE||990030
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP