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Essential Tremor | Limb Cooling in Essential Tremor

Essential Tremor research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Essential Tremor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Limb Cooling Assessment of ETThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Limb Cooling Assessment of ET ControlHealthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.

Limb Cooling Assessment of ET ExperimentalPatients 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.

Study Status

Active, not recruiting

Start Date: October 2014

Completed Date: March 2019

Phase:

Type: Observational

Design:

Primary Outcome: Hand writing assessment battery on limb cooling at 60 minutes post-cooling

Secondary Outcome: Effect of limb cooling on the physiological characteristics of essential tremors.

Study sponsors, principal investigator, and references

Principal Investigator: Aparna W Shukla, M.D

Lead Sponsor: University of Florida

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02067702

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