Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Not Applicable

Completed

• Conditions: Tremor
• Interventions: Other: 15 - 30; Other: 30 - 15

• Registration Number: NCT01093027
• Lead Sponsor: Mayo Clinic

Brief Summary

To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor using a more practical method of limb cooling through a forearm cold pack.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-02-01
• Results First Submitted QC: 2012-03-06
• Results First Posted: 2012-04-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with clinical diagnosis of E.T. for at least a year by a movement disorder neurologist
• A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand
• Ages 18 to 95 years old

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Exclusion Criteria

• (+) sensory loss in the upper extremities
• dermatologic lesions in upper extremities (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash)
• known history of sensitivity to cold (i.e., cold urticaria)
• known peripheral vascular disease
• Raynaud's phenomenon
• scleroderma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
15 - 30	15 - 30	The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
30 - 15	30 - 15	The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.

Primary Outcome Measures

Name	Time	Method
Tremor Amplitude	After 10 minutes of limb cooling treatment.	Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.

Secondary Outcome Measures

Name	Time	Method
Tremor Rating Scale	After 10 minutes of limb cooling treatment.	Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States