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Effect of Alcohol on Tremors

Primary Purpose

Tremor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tremor focused on measuring Inferior Olives, Calcium Channels, Accelerometry, Electromyography, Palatal Tremor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001925
Brief Title
Effect of Alcohol on Tremors
Official Title
Effect of Alcohol on Physiologic and Pathologic Tremors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor
Keywords
Inferior Olives, Calcium Channels, Accelerometry, Electromyography, Palatal Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
23 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alcohol

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3585382
Citation
Homberg V, Hefter H, Reiners K, Freund HJ. Differential effects of changes in mechanical limb properties on physiological and pathological tremor. J Neurol Neurosurg Psychiatry. 1987 May;50(5):568-79. doi: 10.1136/jnnp.50.5.568.
Results Reference
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PubMed Identifier
8849966
Citation
Deuschl G, Krack P, Lauk M, Timmer J. Clinical neurophysiology of tremor. J Clin Neurophysiol. 1996 Mar;13(2):110-21. doi: 10.1097/00004691-199603000-00002.
Results Reference
background
PubMed Identifier
2851115
Citation
Lutes J, Lorden JF, Beales M, Oltmans GA. Tolerance to the tremorogenic effects of harmaline: evidence for altered olivo-cerebellar function. Neuropharmacology. 1988 Aug;27(8):849-55. doi: 10.1016/0028-3908(88)90102-5.
Results Reference
background

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Effect of Alcohol on Tremors

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