ParkinsonTREMORHYTHMNCT05998486
Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity
An observational study of Parkinson and Cerebellar Tumor, run by Henri Mondor University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson, Cerebellar Tumor, Rest Tremor
- What is being tested?
- EMG in wrist flexor-pronators and extensor-supinators
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease or cerebellar tremor diagnosis.
Who may be able to join
- patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories;
- diagnosis of Parkinson's disease or cerebellar tremor.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Emilie Hutin contact
France1 site, 1 recruiting
- Recruiting
Laboratoire Analyse et Restauration du Mouvement
Créteil
Emilie Hutin, PhD, +33149812549, emilie.hutin@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Parkinson, Cerebellar Tumor, Rest Tremor, Diagnoses Disease, Movement; Abnormal, Involuntary
- Being tested
- EMG in wrist flexor-pronators and extensor-supinators
- Medical subject headings
- Cerebellar Neoplasms, Tremor, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG in wrist flexor-pronators and extensor-supinatorsDiagnostic test
The subject is asked to perform a series of tasks: resting posture, symmetrical posture arms forward, unilateral distal movement. Each task lasts 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: EMG in wrist flexor-pronators and extensor-supinators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Apr 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Hutin, Henri Mondor University Hospital
- Investigators
- Emilie Hutin, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998486
- Sponsor's protocol ID
- ARM-Tremor
- Acronym
- TREMORHYTHM
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity
- ClinicalTrials.gov ID
- NCT05998486
- Acronym / sponsor ID
- TREMORHYTHM / ARM-Tremor
- Conditions
- Parkinson, Cerebellar Tumor, Rest Tremor, Diagnoses Disease, Movement; Abnormal, Involuntary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tremor of rest | – | Diagnostic Test: EMG in wrist flexor-pronators and extensor-supinatorsPatient with a diagnosis of Parkinson's disease and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories |
| Cerebellar tremor | – | Diagnostic Test: EMG in wrist flexor-pronators and extensor-supinatorsPatient with a diagnosis of cerebellar tremor and who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators analysis in Laboratories |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease or cerebellar tremor diagnosis.
Key inclusion criteria (2 listed)
- patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories;
- diagnosis of Parkinson's disease or cerebellar tremor.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG in wrist flexor-pronators and extensor-supinatorsThe subject is asked to perform a series of tasks: resting posture, symmetrical posture arms forward, unilateral distal movement. Each task lasts 10 seconds. | Diagnostic test | Cerebellar tremor, Tremor of rest |
Primary outcome
rhythmicity index
Time frame: 10 seconds
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Hutin contact
Emilie Hutin principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson and Cerebellar Tumor, run by Henri Mondor University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Hutin, PhD (+33149812549, emilie.hutin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rhythmicity index (time frame: 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.