Essential TremorNCT02067702
Limb Cooling in Essential Tremor
An observational study of Essential Tremor, run by University of Florida at 1 site in United States.
Trial summary
Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Limb Cooling Assessment of ET
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 14 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24 subjects with no diagnosed of ET.
Who may be able to join
- Age range 18 to 95 years,
- Clinical diagnosis of essential tremor for at least a year,
- A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand
Who cannot join
- Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash),
- Sensory loss in the upper limbs,
- Known history of sensitivity to cold (i.e., cold urticaria),
- Known peripheral vascular disease,
- Raynaud's phenomenon,
- Scleroderma
- Healthy normal controls will be enrolled through advertisements. All controls will be examined to ensure that they are neurologically healthy.
- The exclusion criteria for controls will remain same as those for patient subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Movement Disorders Center
Gainesville, Florida, 32611
About this study
Official title: Effects of Limb Cooling on Essential Tremor.
Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.
Read the detailed description
Once the subject has agreed to participate in the study the following assessments will be performed.
Three non-pharmacological assessments will be performed at different temperature to the upper limbs. The first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°F). The second assessment will be performed with upper limbs at a temperature of 59°F and the third will be performed at a temperature of 80°F for a period of 10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.
- Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
- The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.
- Conditions
- Essential Tremor
- Being tested
- Limb Cooling Assessment of ET
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb Cooling Assessment of ETProcedure or surgery
The non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings.
| Study group | Role | What they receive |
|---|---|---|
| Limb Cooling Assessment of ET Control | Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease. Receives: Procedure: Limb Cooling Assessment of ET | |
| Limb Cooling Assessment of ET Experimental | Patients with known essential tremor for at least a year, and +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand. Receives: Procedure: Limb Cooling Assessment of ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Measured: 60 minutes post-cooling.
Tremor rating scale on limb cooling at 40 minutes post-cooling
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Measured: 40 minutes post-cooling.
Functional dexterity test on limb cooling at 60 minutes post-cooling
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Measured: 60 minutes post-cooling.
Hand writing assessment battery on limb cooling at 15 minutes post-cooling
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Measured: 15 minutes post-cooling.
Hand writing assessment battery on limb cooling at 40 minutes post-cooling
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Measured: 40 minutes post-cooling.
Tremor rating scale on limb cooling at 15 minutes post-cooling
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Measured: 15 minutes post-cooling.
Functional dexterity test on limb cooling at 15 minutes post-cooling
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Measured: 15 minutes post-cooling.
Functional dexterity test on limb cooling at 40 minutes post-cooling
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Measured: 40 minutes post-cooling.
Tremor rating scale on limb cooling at 60 minutes post-cooling
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Measured: 60 minutes post-cooling.
Secondary outcomes (3)
Effect of limb cooling on the physiological characteristics of essential tremors.
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
Measured: 60 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
Measured: 40 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
Measured: 15 minutes post-cooling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna W Shukla, M.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067702
- Sponsor's protocol ID
- IRB201300662
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Limb Cooling on Essential Tremor.
- ClinicalTrials.gov ID
- NCT02067702
- Acronym / sponsor ID
- IRB201300662
- Conditions
- Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.
Detailed description
Once the subject has agreed to participate in the study the following assessments will be performed.
Three non-pharmacological assessments will be performed at different temperature to the upper limbs. The first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°F). The second assessment will be performed with upper limbs at a temperature of 59°F and the third will be performed at a temperature of 80°F for a period of 10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.
- Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
- The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limb Cooling Assessment of ET Control | – | Procedure: Limb Cooling Assessment of ETHealthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease. |
| Limb Cooling Assessment of ET Experimental | – | Procedure: Limb Cooling Assessment of ETPatients with known essential tremor for at least a year, and +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24 subjects with no diagnosed of ET.
Key inclusion criteria (3 listed)
- Age range 18 to 95 years,
- Clinical diagnosis of essential tremor for at least a year,
- A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand
Key exclusion criteria (8 listed)
- Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash),
- Sensory loss in the upper limbs,
- Known history of sensitivity to cold (i.e., cold urticaria),
- Known peripheral vascular disease,
- Raynaud's phenomenon,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limb Cooling Assessment of ETThe non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings. | Procedure or surgery | Limb Cooling Assessment of ET Control, Limb Cooling Assessment of ET Experimental |
Primary outcome
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Time frame: 60 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Tremor rating scale on limb cooling at 40 minutes post-cooling
Time frame: 40 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Functional dexterity test on limb cooling at 60 minutes post-cooling
Time frame: 60 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Hand writing assessment battery on limb cooling at 15 minutes post-cooling
Time frame: 15 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Hand writing assessment battery on limb cooling at 40 minutes post-cooling
Time frame: 40 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Tremor rating scale on limb cooling at 15 minutes post-cooling
Time frame: 15 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Functional dexterity test on limb cooling at 15 minutes post-cooling
Time frame: 15 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Functional dexterity test on limb cooling at 40 minutes post-cooling
Time frame: 40 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Tremor rating scale on limb cooling at 60 minutes post-cooling
Time frame: 60 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
3 secondary outcomes
Effect of limb cooling on the physiological characteristics of essential tremors.
Time frame: 60 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.
Time frame: 40 minutes post-cooling.
Effect of limb cooling on the physiological characteristics of essential tremors.
Time frame: 15 minutes post-cooling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparna W Shukla, M.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand writing assessment battery on limb cooling at 60 minutes post-cooling (time frame: 60 minutes post-cooling.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.