Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Tremor Clinical Trial

Official title:

Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093027
• Other study ID #: 09-007889
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: December 14, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor Amplitude	Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.	After 10 minutes of limb cooling treatment.	No
Secondary	Tremor Rating Scale	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.	After 10 minutes of limb cooling treatment.	No