Trial record 3 of 275 for:    Tremor

Limb Cooling in Essential Tremor

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02067702
First received: February 14, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.


Condition Intervention
Essential Tremor.
Procedure: Limb Cooling Assessment of ET

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Limb Cooling on Essential Tremor.

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Hand writing assessment battery on limb cooling at 60 minutes post-cooling [ Time Frame: 60 minutes post-cooling. ] [ Designated as safety issue: No ]
    Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).

  • Tremor rating scale on limb cooling at 40 minutes post-cooling [ Time Frame: 40 minutes post-cooling. ] [ Designated as safety issue: No ]
    Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.

  • Functional dexterity test on limb cooling at 60 minutes post-cooling [ Time Frame: 60 minutes post-cooling. ] [ Designated as safety issue: No ]
    Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.

  • Hand writing assessment battery on limb cooling at 15 minutes post-cooling [ Time Frame: 15 minutes post-cooling. ] [ Designated as safety issue: No ]
    Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).

  • Hand writing assessment battery on limb cooling at 40 minutes post-cooling [ Time Frame: 40 minutes post-cooling. ] [ Designated as safety issue: No ]
    Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).

  • Tremor rating scale on limb cooling at 15 minutes post-cooling [ Time Frame: 15 minutes post-cooling. ] [ Designated as safety issue: No ]
    Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.

  • Functional dexterity test on limb cooling at 15 minutes post-cooling [ Time Frame: 15 minutes post-cooling. ] [ Designated as safety issue: No ]
    Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.

  • Functional dexterity test on limb cooling at 40 minutes post-cooling [ Time Frame: 40 minutes post-cooling. ] [ Designated as safety issue: No ]
    Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.

  • Tremor rating scale on limb cooling at 60 minutes post-cooling [ Time Frame: 60 minutes post-cooling. ] [ Designated as safety issue: No ]
    Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.


Secondary Outcome Measures:
  • Effect of limb cooling on the physiological characteristics of essential tremors. [ Time Frame: 60 minutes post-cooling. ] [ Designated as safety issue: No ]
    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.

  • Effect of limb cooling on the physiological characteristics of essential tremors. [ Time Frame: 40 minutes post-cooling. ] [ Designated as safety issue: No ]
    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.

  • Effect of limb cooling on the physiological characteristics of essential tremors. [ Time Frame: 15 minutes post-cooling. ] [ Designated as safety issue: No ]
    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.


Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Limb Cooling Assessment of ET Control
Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.
Procedure: Limb Cooling Assessment of ET
The non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings.
Limb Cooling Assessment of ET Experimental
Patients with known essential tremor for at least a year, and +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand.
Procedure: Limb Cooling Assessment of ET
The non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings.

Detailed Description:

Once the subject has agreed to participate in the study the following assessments will be performed.

Three non-pharmacological assessments will be performed at different temperature to the upper limbs. The first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°F). The second assessment will be performed with upper limbs at a temperature of 59°F and the third will be performed at a temperature of 80°F for a period of 10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.

  1. Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
  2. The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24 subjects with no diagnosed of ET.

Criteria

Inclusion Criteria:

  • Age range 18 to 95 years,
  • Clinical diagnosis of essential tremor for at least a year,
  • A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand

Exclusion Criteria:

  • Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash),
  • Sensory loss in the upper limbs,
  • Known history of sensitivity to cold (i.e., cold urticaria),
  • Known peripheral vascular disease,
  • Raynaud's phenomenon,
  • Scleroderma

Healthy normal controls will be enrolled through advertisements. All controls will be examined to ensure that they are neurologically healthy.

The exclusion criteria for controls will remain same as those for patient subjects.

  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: NCT02067702

Contacts
Contact: Aparna W Shukla, M.D 352-294-5400 aparna.shukla@neurology.ufl.edu
Contact: Vinata Vedam-Mai, Ph.D 352-273-9000 vinved@ufl.edu

Locations
United States, Florida
University of Florida, Movement Disorders Center Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Aparna W Shukla, M.D    352-294-5400    aparna.shukla@neurology.ufl.edu   
Contact: Vinata Vedam-Mai, Ph.D    352-273-9000    vinved@ufl.edu   
Principal Investigator: Aparna W Shukla, M.D         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Aparna W Shukla, M.D University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02067702     History of Changes
Other Study ID Numbers: IRB201300662
Study First Received: February 14, 2014
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

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 August 19, 2014