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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014