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To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor using a more practical method of limb cooling through a forearm cold pack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 - 30 | Other | The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2. |
|
| 30 - 15 | Other | The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 - 30 | Other | The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Amplitude | Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test. | After 10 minutes of limb cooling treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Rating Scale | Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe. | After 10 minutes of limb cooling treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virgilio Evidente, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
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Visits were scheduled between June 2010 and December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 - 30 | The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2. |
| FG001 | 30 - 15 | The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| Visit 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 - 30 | The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2. |
| BG001 | 30 - 15 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tremor Amplitude | Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test. | Posted | Mean | Standard Deviation | cm/s^2 | After 10 minutes of limb cooling treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 15 - 30 | The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Virgilio Evidente MD | Mayo Clinic | 480-301-8000 | evidente.virgilio@mayo.edu |
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| ID | Term |
|---|---|
| D014202 | Tremor |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 30 - 15 | Other | The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2. |
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| NOT COMPLETED |
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The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Tremor Rating Scale | Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe. | Posted | Mean | Standard Deviation | units on a scale | After 10 minutes of limb cooling treatment. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 30 - 15 | The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2. | 0 | 10 | 0 | 10 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |