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Completed

NCT Number: NCT01093027

Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor

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.

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Key information

Conditions

Tremor Central Nervous System Diseases Dyskinesias Essential Tremor Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

15 - 30

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

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.

Primary outcomes

  1. Tremor Amplitude

    Time frame: 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 outcomes

  1. Tremor Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2010
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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