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Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

NCT ID: NCT01093027

Last Updated: 2012-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Tremor

Keywords

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Essential Tremor Cooling Temperature Patients with Essential Tremor involving the upper limbs with at least moderate tremor.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type OTHER

15 - 30

Intervention Type OTHER

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.

Group Type OTHER

30 - 15

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Virgilio Evidente, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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09-007889

Identifier Type: -

Identifier Source: org_study_id