Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
April 3, 2012
CompletedDecember 19, 2012
December 1, 2012
1.8 years
March 24, 2010
February 1, 2012
December 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Tremor Rating Scale
After 10 minutes of limb cooling treatment.
Study Arms (2)
15 - 30
OTHERThe 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
OTHERThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- (+) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Virgilio Evidente MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Virgilio Evidente, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 25, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 19, 2012
Results First Posted
April 3, 2012
Record last verified: 2012-12