Tremor
Conditions
Keywords
Essential Tremor, Cooling, Temperature, Patients with Essential Tremor involving the upper limbs with at least moderate tremor.
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.
Interventions
OTHER15 - 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.
OTHER30 - 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Visits were scheduled between June 2010 and December 2011.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | 15 - 30 | 30 - 15 | Total |
|---|---|---|---|
| Age Continuous | 71.2 years STANDARD_DEVIATION 6.8 | 76.3 years STANDARD_DEVIATION 4.9 | 73.8 years STANDARD_DEVIATION 6.3 |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Tremor Amplitude
Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.
Time frame: After 10 minutes of limb cooling treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 15 - 30 | Tremor Amplitude | Visit 1 | 127 cm/s^2 | Standard Deviation 50 |
| 15 - 30 | Tremor Amplitude | Visit 2 | 150 cm/s^2 | Standard Deviation 73 |
| 30 - 15 | Tremor Amplitude | Visit 1 | 104 cm/s^2 | Standard Deviation 44 |
| 30 - 15 | Tremor Amplitude | Visit 2 | 100 cm/s^2 | Standard Deviation 58 |
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.
Time frame: After 10 minutes of limb cooling treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 15 - 30 | Tremor Rating Scale | Visit 1 | 1.35 units on a scale | Standard Deviation 0.61 |
| 15 - 30 | Tremor Rating Scale | Visit 2 | 1.68 units on a scale | Standard Deviation 0.65 |
| 30 - 15 | Tremor Rating Scale | Visit 1 | 1.65 units on a scale | Standard Deviation 0.49 |
| 30 - 15 | Tremor Rating Scale | Visit 2 | 1.32 units on a scale | Standard Deviation 0.47 |