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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05998486
Other study ID # ARM-Tremor
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Henri Mondor University Hospital
Contact Emilie Hutin, PhD
Phone +33149812549
Email emilie.hutin@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and track during disease progression. This study propose to explore the rhythmicity of distal muscle contractions in the upper limb to characterize resting tremor and discriminate it from cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.


Description:

This retrospective study analyzed surface EMG recordings of wrist flexor-pronators and extensor-supinators from patients with PD or CT bilaterally in five 10-second conditions: rest with contralateral motor distraction, symmetrical arms extended forward posture with hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories; - diagnosis of Parkinson's disease or cerebellar tremor. Exclusion Criteria: - Botulinium toxin injection in upper limb during a delay of 3 months before surface EMG recordings; - Levodopa drugs administrated during a delay of 12 hours before surface EMG recordings; - Tremor-favour drugs administrated during a delay of 30 days before surface EMG recordings; - Presence of an other neurologic disease or of any disease associated with motor disorders in upper limb.

Study Design


Intervention

Diagnostic Test:
EMG in wrist flexor-pronators and extensor-supinators
The subject is asked to perform a series of tasks: resting posture, symmetrical posture arms forward, unilateral distal movement. Each task lasts 10 seconds.

Locations

Country Name City State
France Laboratoire Analyse et Restauration du Mouvement Créteil

Sponsors (1)

Lead Sponsor Collaborator
Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary rhythmicity index The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz. 10 seconds
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