- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02067702
Limb Cooling in Essential Tremor
Effects of Limb Cooling on Essential Tremor.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Florida
-
Gainesville, Florida, États-Unis, 32611
- University of Florida, Movement Disorders Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Effect of limb cooling on the physiological characteristics of essential tremors.
Délai: 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.
Délai: 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.
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Aparna W Shukla, M.D, University of Florida
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB201300662
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