Limb Cooling in Essential Tremor

Essential Tremor Clinical Trial

Official title:

Effects of Limb Cooling on Essential Tremor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067702
• Other study ID #: IRB201300662
• Status: Completed
• Start date: October 2014
• Est. completion date: January 14, 2019

Study information

• Verified date: January 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 14, 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida, Movement Disorders Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, ? = 1.0; dot subtest, ? = 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.
Primary	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.
Primary	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.
Primary	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, ? = 1.0; dot subtest, ? = 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.
Primary	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, ? = 1.0; dot subtest, ? = 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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.

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