Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Study Overview
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Brief Summary
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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.

Official Title
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Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Conditions
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Tremor

Intervention / Treatment
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* Other: 15 - 30
* Other: 30 - 15


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical diagnosis of E.T. for at least a year by a movement disorder neurologist A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand Ages 18 to 95 years old Exclusion Criteria: (+) sensory loss in the upper extremities dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash) known history of sensitivity to cold (i.e., cold urticaria) known peripheral vascular disease Raynaud's phenomenon scleroderma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 15 - 30<br>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. | Other: 15 - 30<br>* 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.<br>|
| Other: 30 - 15<br>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. | Other: 30 - 15<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential Tremor, Cooling, Temperature, Patients with Essential Tremor involving the upper limbs with at least moderate tremor.