Limb Cooling in Essential Tremor
16 de enero de 2019 actualizado por: University of Florida
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
27
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- University of Florida, Movement Disorders Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 95 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24 subjects with no diagnosed of ET.
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Limb Cooling Assessment of ET Control
Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.
|
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.
|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Periodo de tiempo: 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).
|
60 minutes post-cooling.
|
|
Tremor rating scale on limb cooling at 40 minutes post-cooling
Periodo de tiempo: 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.
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40 minutes post-cooling.
|
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Functional dexterity test on limb cooling at 60 minutes post-cooling
Periodo de tiempo: 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.
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60 minutes post-cooling.
|
|
Hand writing assessment battery on limb cooling at 15 minutes post-cooling
Periodo de tiempo: 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).
|
15 minutes post-cooling.
|
|
Hand writing assessment battery on limb cooling at 40 minutes post-cooling
Periodo de tiempo: 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).
|
40 minutes post-cooling.
|
|
Tremor rating scale on limb cooling at 15 minutes post-cooling
Periodo de tiempo: 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.
|
15 minutes post-cooling.
|
|
Functional dexterity test on limb cooling at 15 minutes post-cooling
Periodo de tiempo: 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.
|
15 minutes post-cooling.
|
|
Functional dexterity test on limb cooling at 40 minutes post-cooling
Periodo de tiempo: 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.
|
40 minutes post-cooling.
|
|
Tremor rating scale on limb cooling at 60 minutes post-cooling
Periodo de tiempo: 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.
|
60 minutes post-cooling.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effect of limb cooling on the physiological characteristics of essential tremors.
Periodo de tiempo: 60 minutes post-cooling.
|
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
|
60 minutes post-cooling.
|
|
Effect of limb cooling on the physiological characteristics of essential tremors.
Periodo de tiempo: 40 minutes post-cooling.
|
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
|
40 minutes post-cooling.
|
|
Effect of limb cooling on the physiological characteristics of essential tremors.
Periodo de tiempo: 15 minutes post-cooling.
|
To determine the physiological change in response to limb cooling, secondary outcome measures will include surface electromyography (EMG) with accelerometry.
|
15 minutes post-cooling.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Aparna W Shukla, M.D, University of Florida
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2014
Finalización primaria (Actual)
1 de agosto de 2016
Finalización del estudio (Actual)
14 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
14 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
18 de febrero de 2014
Publicado por primera vez (Estimar)
20 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
16 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB201300662
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Ensayos clínicos sobre Temblor esencial
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Xiangya Hospital of Central South UniversityInscripción por invitación