Clinical Trials Directory

Trials / Completed

CompletedNCT02067702

Limb Cooling in Essential Tremor

Effects of Limb Cooling on Essential Tremor.

Status
Completed
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELimb 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.

Timeline

Start date
2014-10-01
Primary completion
2016-08-01
Completion
2019-01-14
First posted
2014-02-20
Last updated
2019-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02067702. Inclusion in this directory is not an endorsement.