Orthostatic TremorEMG-SOTNCT04844203
Prevalence of Orthostatic Tremor in Patients With Unsteadiness
An observational study of Orthostatic Tremor and Neuropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Clinical presentation of orthostatic tremor (OT) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. In addition, peripheral neuropathies represent the leading cause of pathologies associated with OT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Tremor, Neuropathy
- What is being tested?
- Polygraphy with surface electrodes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2021to Apr 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Any patient referred to the Clinical physiology Department for an ENMG (investigation of the neuropathy)
Who may be able to join
- Age ≥ 18 years old
- All patients complaining of instability when standing up and referred for an ENMG
- Patient informed and having expressed his non-opposition to participating in the research
Who cannot join
- Patient's refusal to participate in the study
- Impossibility to stand
- No affiliation to health insurance
- Patients under a legal protection measure or unable to express their will
- Patient under the State Medical Assistance (AME)
- Patient under 18 years old
- Pregnant women, parturients and breast-feeding mothers
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, 75010
Nathalie KUBIS, MD, PhD, +33149958108, nathalie.kubis@aphp.fr
Pierre LOZERON, MD, PhD, +33149958076, pierre.lozeron@aphp.fr
About this study
Official title: Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness
Clinical presentation of orthostatic tremor (OT) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. In addition, peripheral neuropathies represent the leading cause of pathologies associated with OT. Among patients referred for an electroneuromyogram (ENMG) for peripheral neuropathy and presenting with postural unsteadiness, OT assessment will be systematically performed. Demographic, clinical and polygraphy characteristics of these patients will be analyzed and prevalence of OT in the general population of peripheral neuropathies will be assessed.
Read the detailed description
Among patients who will be referred for ENMG and exploration of a neuropathy, orthostatic tremor will be investigated systematically.
Main objective and primary endpoint:
- To estimate the prevalence of OT with its 95% confidence interval in the population of patients defined above
- Presence of OT confirmed by surface EMG (polygraphy) in patients with standing instability referred for ENMG.
Secondary objectives and end points
- Determine the demographic, clinical, electrophysiological characteristics of patients with OT; Estimate the prevalence of peripheral neuropathy in patients with OT; Duration of symptoms; Correlation with quantitative neuropathy scores (ISS, MRC, ONLS, R-ODS)
- Age, sex, clinical parameters: symptoms reported by the patient (instability, tremor, weakness, pain, falls), duration, current medications, ISS score, MRC score, ONLS score, R-ODS score) and electrophysiological parameters (mean frequency of OT in Hertz, MUNIX score (number of motor units in the anterior tibialis, calculated by software on the ENMG machine).
- Conditions
- Orthostatic Tremor, Neuropathy
- Being tested
- Polygraphy with surface electrodes
- Keywords
- Electroneuromyography, Polygraphy, Unsteadiness, Tremor, Anti-MAG neuropathy, Chronic demyelinating inflammatory neuropathy
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygraphy with surface electrodesDiagnostic test
Patients referred for ENMG to the Clinical Physiology Department and complaining of postural unsteadiness will undergo a polygraphy recording using surface electrodes (Natus Medical Incorporated), performed at the end of ENMG
| Study group | Role | What they receive |
|---|---|---|
| Patients with unsteadiness | Patients with unsteadiness referred for an ENMG Receives: Diagnostic Test: Polygraphy with surface electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of orthostatic tremor (OT
Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG
Measured: Day 0
Secondary outcomes (6)
Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified
The ISS ranges from 0 (normal sensation) to 20 (most severe sensory deficit) and is composed of the summation of the following sensation evaluations : pinprick arm grade (range 0-4) ; vibration arm grade (range 0-4) ; pinprick leg grade (range 0-4); vibration leg grade (range 0-4): two-point discrimination grade (range 0-4)
Measured: Day 0
Medical Research Council (MRC) score
The MRC score grades muscle power on a scale of 0 (no detectable contraction) to 5 (normal force, comparable to the healthy side)
Measured: Day 0
Overall Neuropathy Limitations Scale (ONLS) score
The ONLS score is be completed by adding the total of the Arm disability scale score (0-5) and Leg disability scale score (0-7) yielding a total score of 0-12 (higher score indicates higher disability)
Measured: Day 0
Rasch-built Overall Disability Scale (R-ODS) score
R-ODS scale comprising 24 items evaluates the ability to perform daily activities. The answers are rated on a scale of 0 to 48 (with 0 being very poor and 48 being best performance)
Measured: Day 0
OT frequency
OT frequency in Hz
Measured: Day 0
Motor unit number index (MUNIX)
MUNIX is a method for assessment of number of motor units using the compound muscle action potential (CMAP) and surface electromyographic interference pattern (SIP).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start27 Apr 2021
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic TremorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie KUBIS, MD, PhD, Principal investigator, APHP, Lariboisière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844203
- Sponsor's protocol ID
- APHP191089
- Other IDs
- 2019-A02976-51
- Acronym
- EMG-SOT
- Status last verified
- Jan 2024
- First submitted
- 9 Apr 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness
- ClinicalTrials.gov ID
- NCT04844203
- Acronym / sponsor ID
- EMG-SOT / APHP191089
- Conditions
- Orthostatic Tremor, Neuropathy
- Keywords
- Electroneuromyography, Polygraphy, Unsteadiness, Tremor, Anti-MAG neuropathy, Chronic demyelinating inflammatory neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Apr 2021 (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.
Clinical presentation of orthostatic tremor (OT) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. In addition, peripheral neuropathies represent the leading cause of pathologies associated with OT. Among patients referred for an electroneuromyogram (ENMG) for peripheral neuropathy and presenting with postural unsteadiness, OT assessment will be systematically performed. Demographic, clinical and polygraphy characteristics of these patients will be analyzed and prevalence of OT in the general population of peripheral neuropathies will be assessed.
Detailed description
Among patients who will be referred for ENMG and exploration of a neuropathy, orthostatic tremor will be investigated systematically.
Main objective and primary endpoint:
- To estimate the prevalence of OT with its 95% confidence interval in the population of patients defined above
- Presence of OT confirmed by surface EMG (polygraphy) in patients with standing instability referred for ENMG.
Secondary objectives and end points
- Determine the demographic, clinical, electrophysiological characteristics of patients with OT; Estimate the prevalence of peripheral neuropathy in patients with OT; Duration of symptoms; Correlation with quantitative neuropathy scores (ISS, MRC, ONLS, R-ODS)
- Age, sex, clinical parameters: symptoms reported by the patient (instability, tremor, weakness, pain, falls), duration, current medications, ISS score, MRC score, ONLS score, R-ODS score) and electrophysiological parameters (mean frequency of OT in Hertz, MUNIX score (number of motor units in the anterior tibialis, calculated by software on the ENMG machine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unsteadiness | – | Diagnostic Test: Polygraphy with surface electrodesPatients with unsteadiness referred for an ENMG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patient referred to the Clinical physiology Department for an ENMG (investigation of the neuropathy)
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- All patients complaining of instability when standing up and referred for an ENMG
- Patient informed and having expressed his non-opposition to participating in the research
Key exclusion criteria (7 listed)
- Patient's refusal to participate in the study
- Impossibility to stand
- No affiliation to health insurance
- Patients under a legal protection measure or unable to express their will
- Patient under the State Medical Assistance (AME)
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 |
|---|---|---|
| Polygraphy with surface electrodesPatients referred for ENMG to the Clinical Physiology Department and complaining of postural unsteadiness will undergo a polygraphy recording using surface electrodes (Natus Medical Incorporated), performed at the end of ENMG | Diagnostic test | Patients with unsteadiness |
Primary outcome
Prevalence of orthostatic tremor (OT
Time frame: Day 0
Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG
6 secondary outcomes
Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified
Time frame: Day 0
Medical Research Council (MRC) score
Time frame: Day 0
Overall Neuropathy Limitations Scale (ONLS) score
Time frame: Day 0
Rasch-built Overall Disability Scale (R-ODS) score
Time frame: Day 0
OT frequency
Time frame: Day 0
Motor unit number index (MUNIX)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
Nathalie KUBIS, MD, PhD principal investigator
APHP, Lariboisière 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 Orthostatic Tremor and Neuropathy, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 7 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 3 Jan 2024. 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 Nathalie KUBIS, MD, PhD (+33149958108, nathalie.kubis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of orthostatic tremor (OT (time frame: Day 0). 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 3 Jan 2024.