Limb Cooling in Essential Tremor

University of Florida

Status: Completed

Conditions: Essential Tremor

Treatments: Procedure: Limb Cooling Assessment of ET

Study type: Observational

Funder types: Other

Identifiers

NCT02067702

IRB201300662

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

27 participants in 2 patient groups

Limb Cooling Assessment of ET Control

Description:

Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.

Treatment:

Procedure: Limb Cooling Assessment of ET

Limb Cooling Assessment of ET Experimental

Description:

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.

Treatment:

Procedure: Limb Cooling Assessment of ET