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Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

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ClinicalTrials.gov Identifier: NCT01093027
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : April 3, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tremor Other: 15 - 30 Other: 30 - 15 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: 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.
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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tremor Amplitude [ Time Frame: After 10 minutes of limb cooling treatment. ]
    Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.


Secondary Outcome Measures :
  1. Tremor Rating Scale [ Time Frame: After 10 minutes of limb cooling treatment. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093027


Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Virgilio Evidente, MD Mayo Clinic
More Information
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Responsible Party: Virgilio Evidente, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093027    
Other Study ID Numbers: 09-007889
First Posted: March 25, 2010    Key Record Dates
Results First Posted: April 3, 2012
Last Update Posted: December 19, 2012
Last Verified: December 2012
Keywords provided by Mayo Clinic:
Essential Tremor
Cooling
Temperature
Patients with Essential Tremor involving the upper limbs with at least moderate tremor.
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases