Clinical trial NCT02067702: Limb Cooling in Essential Tremor
Official title: Effects of Limb Cooling on Essential Tremor.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: Hand writing assessment battery on limb cooling at 60 minutes post-cooling
timeFrame: 60 minutes post-cooling.
measure: Tremor rating scale on limb cooling at 40 minutes post-cooling
timeFrame: 40 minutes post-cooling.
measure: Functional dexterity test on limb cooling at 60 minutes post-cooling
timeFrame: 60 minutes post-cooling.
measure: Hand writing assessment battery on limb cooling at 15 minutes post-cooling
timeFrame: 15 minutes post-cooling.
measure: Hand writing assessment battery on limb cooling at 40 minutes post-cooling
timeFrame: 40 minutes post-cooling.
measure: Tremor rating scale on limb cooling at 15 minutes post-cooling
timeFrame: 15 minutes post-cooling.
measure: Functional dexterity test on limb cooling at 15 minutes post-cooling
timeFrame: 15 minutes post-cooling.
measure: Functional dexterity test on limb cooling at 40 minutes post-cooling
timeFrame: 40 minutes post-cooling.
measure: Tremor rating scale on limb cooling at 60 minutes post-cooling
timeFrame: 60 minutes post-cooling.
Secondary outcomes:
measure: Effect of limb cooling on the physiological characteristics of essential tremors.
timeFrame: 60 minutes post-cooling.
measure: Effect of limb cooling on the physiological characteristics of essential tremors.
timeFrame: 40 minutes post-cooling.
measure: Effect of limb cooling on the physiological characteristics of essential tremors.
timeFrame: 15 minutes post-cooling.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Movement Disorders Center
state: Florida
Study officials:
affiliation: University of Florida
name: Aparna W Shukla, M.D
role: PRINCIPAL_INVESTIGATOR
References: