Limb Cooling in Essential Tremor

Effects of Limb Cooling on 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.

Study Overview

• Status: Completed
• Conditions: Essential Tremor
• Intervention / Treatment: Procedure: Limb Cooling Assessment of ET

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida, Movement Disorders Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand writing assessment battery on limb cooling at 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).	60 minutes post-cooling.
Tremor rating scale on limb cooling at 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.	40 minutes post-cooling.
Functional dexterity test on limb cooling at 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.	60 minutes post-cooling.
Hand writing assessment battery on limb cooling at 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).	15 minutes post-cooling.
Hand writing assessment battery on limb cooling at 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).	40 minutes post-cooling.
Tremor rating scale on limb cooling at 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.	15 minutes post-cooling.
Functional dexterity test on limb cooling at 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.	15 minutes post-cooling.
Functional dexterity test on limb cooling at 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.	40 minutes post-cooling.
Tremor rating scale on limb cooling at 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.	60 minutes post-cooling.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of limb cooling on the physiological characteristics of essential tremors.	To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.	60 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.	To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.	40 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.	To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.	15 minutes post-cooling.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Aparna W Shukla, M.D, University of Florida

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: IRB201300662