NCT05998486

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 7, 2023

Last Update Submit

August 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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 tremorTremor of rest

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease or cerebellar tremor diagnosis.

You may qualify if:

  • patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories;
  • diagnosis of Parkinson's disease or cerebellar tremor.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire Analyse et Restauration du Mouvement

Créteil, France

RECRUITING

MeSH Terms

Conditions

Cerebellar NeoplasmsTremorAntisocial Personality Disorder

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Infratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebellar DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Emilie Hutin

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Hutin, PhD

CONTACT

Emilie Hutin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-director of laboratory

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 21, 2023

Study Start

April 3, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations