TremorPhase 2NCT00001925
Effect of Alcohol on Tremors
A Phase 2 study testing Alcohol in people with Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tremor
- What is being tested?
- Alcohol
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Jul 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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).
Read the 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.
- Conditions
- Tremor
- Being tested
- Alcohol
- Keywords
- Inferior Olives, Calcium Channels, Accelerometry, Electromyography, Palatal Tremor
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJan 1999
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 23 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001925
- Sponsor's protocol ID
- 990030
- Other IDs
- 99-N-0030
- Status last verified
- Jul 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 3585382Deuschl 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.
PubMed 8849966Lutes 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.
PubMed 2851115
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alcohol on Physiologic and Pathologic Tremors
- ClinicalTrials.gov ID
- NCT00001925
- Acronym / sponsor ID
- 990030
- Conditions
- Tremor
- Keywords
- Inferior Olives, Calcium Channels, Accelerometry, Electromyography, Palatal Tremor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 1999
- Study completion
- Jul 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3585382Homberg 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.
- Background: PubMed 8849966Deuschl 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.
- Background: PubMed 2851115Lutes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alcohol in people with Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001925, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.