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Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01093027
First received: March 24, 2010
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Tremor
 Other: 15 - 30
Other: 30 - 15

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Tremor Amplitude [ Time Frame: After 10 minutes of limb cooling treatment. ] [ Designated as safety issue: No ]
    Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.


Secondary Outcome Measures:
  • Tremor Rating Scale [ Time Frame: After 10 minutes of limb cooling treatment. ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093027

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virgilio Evidente, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Virgilio Evidente, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093027     History of Changes
Other Study ID Numbers: 09-007889
Study First Received: March 24, 2010
Results First Received: February 1, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

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:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013