Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity (TREMORHYTHM)

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.

Study Overview

• Status: Recruiting
• Conditions: Diagnoses Disease; Parkinson; Rest Tremor; Cerebellar Tumor; Movement; Abnormal, Involuntary
• Intervention / Treatment: Diagnostic test: EMG in wrist flexor-pronators and extensor-supinators

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Emilie Hutin, PhD; Phone Number: +33149812549; Email: emilie.hutin@aphp.fr
• Study Contact Backup: Name: Emilie Hutin; Email: emilie.hutin@aphp.fr

Study Locations

• France
  • Créteil, France
    • Recruiting
    • Laboratoire Analyse et Restauration du Mouvement
    • Contact: Emilie Hutin, PhD; Phone Number: +33149812549; Email: emilie.hutin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease or cerebellar tremor diagnosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tremor of rest; Patient with a diagnosis of Parkinson's disease and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories	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.
Cerebellar tremor; Patient with a diagnosis of cerebellar tremor and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital
• Investigators: Principal Investigator: Emilie Hutin, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Cerebellar Diseases; Infratentorial Neoplasms; Parkinson Disease; Tremor; Cerebellar Neoplasms
• Other Study ID Numbers: ARM-Tremor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No