Back to resultsElectrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Primary Purpose
Tremor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
15 - 30
30 - 15
Sponsored by
About this trial
This is an interventional treatment trial for Tremor focused on measuring Essential Tremor, Cooling, Temperature, Patients with Essential Tremor involving the upper limbs with at least moderate tremor.
Eligibility 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
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
15 - 30
30 - 15
Arm Description
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.
Outcomes
Primary Outcome Measures
Tremor Amplitude
Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093027
Brief Title
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Official Title
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tremor
Keywords
Essential Tremor, Cooling, Temperature, Patients with Essential Tremor involving the upper limbs with at least moderate tremor.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15 - 30
Arm Type
Other
Arm Description
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.
Arm Title
30 - 15
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
15 - 30
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
30 - 15
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tremor Amplitude
Description
Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.
Time Frame
After 10 minutes of limb cooling treatment.
Secondary Outcome Measure Information:
Title
Tremor Rating Scale
Description
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.
Time Frame
After 10 minutes of limb cooling treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgilio Evidente, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
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