Skip to main content
OpenTrials
Completed

NCT Number: NCT02067702

Limb Cooling in Essential Tremor

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Movement Disorders Center

Gainesville, Florida, 32611, United States

About this study

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Limb Cooling Assessment of ET

Procedure

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.

Primary outcomes

  1. Hand writing assessment battery on limb cooling at 60 minutes post-cooling

    Time frame: 60 minutes post-cooling.

    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).

  2. Tremor rating scale on limb cooling at 40 minutes post-cooling

    Time frame: 40 minutes post-cooling.

    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.

  3. Functional dexterity test on limb cooling at 60 minutes post-cooling

    Time frame: 60 minutes post-cooling.

    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.

  4. Hand writing assessment battery on limb cooling at 15 minutes post-cooling

    Time frame: 15 minutes post-cooling.

    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).

  5. Hand writing assessment battery on limb cooling at 40 minutes post-cooling

    Time frame: 40 minutes post-cooling.

    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).

  6. Tremor rating scale on limb cooling at 15 minutes post-cooling

    Time frame: 15 minutes post-cooling.

    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.

  7. Functional dexterity test on limb cooling at 15 minutes post-cooling

    Time frame: 15 minutes post-cooling.

    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.

  8. Functional dexterity test on limb cooling at 40 minutes post-cooling

    Time frame: 40 minutes post-cooling.

    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.

  9. Tremor rating scale on limb cooling at 60 minutes post-cooling

    Time frame: 60 minutes post-cooling.

    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 outcomes

  1. Effect of limb cooling on the physiological characteristics of essential tremors.

    Time frame: 60 minutes post-cooling.

    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.

  2. Effect of limb cooling on the physiological characteristics of essential tremors.

    Time frame: 40 minutes post-cooling.

    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.

  3. Effect of limb cooling on the physiological characteristics of essential tremors.

    Time frame: 15 minutes post-cooling.

    To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Effects of Limb Cooling on Essential Tremor.

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Feb 20, 2014
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.