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Limb Cooling in Essential Tremor

16. januar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

27

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Florida
      • Gainesville, Florida, Forente stater, 32611
        • University of Florida, Movement Disorders Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 95 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Limb Cooling Assessment of ET Control
Healthy, volunteers with no known dermatological lesions, sensitivity to cold, or peripheral vascular disease.
Fremgangsmåte: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effect of limb cooling on the physiological characteristics of essential tremors.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.

Samarbeidspartnere og etterforskere

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Sponsor

University of Florida

Etterforskere

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

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2014

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

14. januar 2019

Datoer for studieregistrering

Først innsendt

14. februar 2014

Først innsendt som oppfylte QC-kriteriene

18. februar 2014

Først lagt ut (Anslag)

20. februar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB201300662

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