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Limb Cooling in Essential Tremor

16. ledna 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

  1. Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
  2. The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.

Typ studie

Pozorovací

Zápis (Aktuální)

27

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Florida
      • Gainesville, Florida, Spojené státy, 32611
        • University of Florida, Movement Disorders Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 95 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24 subjects with no diagnosed of ET.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Limb Cooling Assessment of ET Control
Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.
Postup: Limb Cooling Assessment of ET
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.
Postup: Limb Cooling Assessment of ET
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Časové okno: 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
Časové okno: 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.
40 minutes post-cooling.
Functional dexterity test on limb cooling at 60 minutes post-cooling
Časové okno: 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.
60 minutes post-cooling.
Hand writing assessment battery on limb cooling at 15 minutes post-cooling
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Effect of limb cooling on the physiological characteristics of essential tremors.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Florida

Vyšetřovatelé

  • Vrchní vyšetřovatel: Aparna W Shukla, M.D, University of Florida

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2014

Primární dokončení (Aktuální)

1. srpna 2016

Dokončení studie (Aktuální)

14. ledna 2019

Termíny zápisu do studia

První předloženo

14. února 2014

První předloženo, které splnilo kritéria kontroly kvality

18. února 2014

První zveřejněno (Odhad)

20. února 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. ledna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. ledna 2019

Naposledy ověřeno

1. ledna 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB201300662

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