MyoclonusNCT04235452
Electrophysiological Characteristics and Anatomical Differentiation of Epileptic and Non-epileptic Myoclonus.
An observational study of Myoclonus and Evoked Potential, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
This study was conducted on a series of patients with myoclonus to identify the electrophysiological characteristics and the anatomical classification of myoclonus of different causes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myoclonus, Evoked Potential
- What is being tested?
- Somatosensory evoked potential
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 31 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 50 patients with myoclonus of different etiologies (primary and secondary myoclonus).
Who may be able to join
- Myoclonus classified into primary and secondary myoclonus.
Who cannot join
- Psychiatric comorbidity to exclude psychological myoclonus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
This study was conducted on a series of patients with myoclonus to identify the electrophysiological characteristics and the anatomical classification of myoclonus of different causes.
Read the detailed description
The current study included 50 patients with different types of myoclonus in comparison to 30 control subjects. Electrophysiological study was done for all patients by Somatosensory Evoked Potential (SSEP) and Electroencephalography (EEG) while the control group underwent SSEP. SSEP was studied in the patients and control group by stimulation of right and left median nerves.
- Conditions
- Myoclonus, Evoked Potential
- Being tested
- Somatosensory evoked potential
- Keywords
- Myoclonus, Evoked potential
- Medical subject headings
- Myoclonus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory evoked potentialDiagnostic test
Stimulation of the right and left median nerves for each subject were carried out with electrical square wave pulses of 0.2 ms duration applied at a rate of 5 HZ. with cathode proximally. The intensity of the stimulus was adjusted to produce minimal twitches of the thumb (1-2 cm thumb movement). Five hundred (500) stimuli were delivered. The recording electrode picked up the responses. They were then summated and averaged.
The final evoked potential was then displayed on the screen. When two reproducible SEPs responses were obtained the data was accepted for analysis. The graph was printed out on paper, for the purpose of simplification only one response was printed out.
| Study group | Role | What they receive |
|---|---|---|
| Epileptic myoclonus | Juvenile Myoclonic Epilepsy and Progressive Myoclonic Epilepsy Receives: Diagnostic Test: Somatosensory evoked potential | |
| Non-epileptic myoclonus (secondary) | Post hypoxic myoclonus, Post ischemic stroke myoclonus, Hepatic, Chronic kidney disease, and Drug induced myoclonus Receives: Diagnostic Test: Somatosensory evoked potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory evoked potential
Stimulation of the right and left median nerves for each subject were carried out with electrical square wave pulses of 0.2 ms duration applied at a rate of 5 HZ. with cathode proximally. The intensity of the stimulus was adjusted to produce minimal twitches of the thumb (1-2 cm thumb movement). Five hundred (500) stimuli were delivered. The recording electrode picked up the responses. They were then summated and averaged.
The final evoked potential was then displayed on the screen. When two reproducible SEPs responses were obtained the data was accepted for analysis. The graph was printed out on paper, for the purpose of simplification only one response was printed out.
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Nov 2018
- Primary completion31 Aug 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyoclonusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235452
- Sponsor's protocol ID
- Mansoura University 11
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdo WF, van de Warrenburg BP, Burn DJ, Quinn NP, Bloem BR. The clinical approach to movement disorders. Nat Rev Neurol. 2010 Jan;6(1):29-37. doi: 10.1038/nrneurol.2009.196.
PubMed 20057497Agarwal P, Frucht SJ. Myoclonus. Curr Opin Neurol. 2003 Aug;16(4):515-21. doi: 10.1097/01.wco.0000084231.82329.9c.
PubMed 12869812Alvarez, V. & Rossetti, A. O. 2015. Electroencephalography and Evoked Potentials: Technical Background. Clinical Neurophysiology in Disorders of Consciousness. Springer. 7-23.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Characteristics and Anatomical Differentiation of Epileptic and Non-epileptic Myoclonus.
- ClinicalTrials.gov ID
- NCT04235452
- Acronym / sponsor ID
- Mansoura University 11
- Conditions
- Myoclonus, Evoked Potential
- Keywords
- Myoclonus, Evoked potential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Jan 2020 (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.
This study was conducted on a series of patients with myoclonus to identify the electrophysiological characteristics and the anatomical classification of myoclonus of different causes.
Detailed description
The current study included 50 patients with different types of myoclonus in comparison to 30 control subjects. Electrophysiological study was done for all patients by Somatosensory Evoked Potential (SSEP) and Electroencephalography (EEG) while the control group underwent SSEP. SSEP was studied in the patients and control group by stimulation of right and left median nerves.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epileptic myoclonus | – | Diagnostic Test: Somatosensory evoked potentialJuvenile Myoclonic Epilepsy and Progressive Myoclonic Epilepsy |
| Non-epileptic myoclonus (secondary) | – | Diagnostic Test: Somatosensory evoked potentialPost hypoxic myoclonus, Post ischemic stroke myoclonus, Hepatic, Chronic kidney disease, and Drug induced myoclonus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 patients with myoclonus of different etiologies (primary and secondary myoclonus).
Key inclusion criteria (1 listed)
- Myoclonus classified into primary and secondary myoclonus.
Key exclusion criteria (1 listed)
- Psychiatric comorbidity to exclude psychological myoclonus.
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 |
|---|---|---|
| Somatosensory evoked potentialStimulation of the right and left median nerves for each subject were carried out with electrical square wave pulses of 0.2 ms duration applied at a rate of 5 HZ. with cathode proximally. The intensity of the stimulus was adjusted to produce minimal twitches of the thumb (1-2 cm thumb movement). Five hundred (500) stimuli were delivered. The recording electrode picked up the responses. They were then summated and averaged. The final evoked potential was then displayed on the screen. When two reproducible SEPs responses were obtained the data was accepted for analysis. The graph was printed out on paper, for the purpose of simplification only one response was printed out. | Diagnostic test | Epileptic myoclonus, Non-epileptic myoclonus (secondary) |
Primary outcome
Somatosensory evoked potential
Time frame: 24-72 hours
Stimulation of the right and left median nerves for each subject were carried out with electrical square wave pulses of 0.2 ms duration applied at a rate of 5 HZ. with cathode proximally. The intensity of the stimulus was adjusted to produce minimal twitches of the thumb (1-2 cm thumb movement). Five hundred (500) stimuli were delivered. The recording electrode picked up the responses. They were then summated and averaged. The final evoked potential was then displayed on the screen. When two reproducible SEPs responses were obtained the data was accepted for analysis. The graph was printed out on paper, for the purpose of simplification only one response was printed out.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Results publication: PubMed 20057497Abdo WF, van de Warrenburg BP, Burn DJ, Quinn NP, Bloem BR. The clinical approach to movement disorders. Nat Rev Neurol. 2010 Jan;6(1):29-37. doi: 10.1038/nrneurol.2009.196.
- Results publication: PubMed 12869812Agarwal P, Frucht SJ. Myoclonus. Curr Opin Neurol. 2003 Aug;16(4):515-21. doi: 10.1097/01.wco.0000084231.82329.9c.
- Results publicationAlvarez, V. & Rossetti, A. O. 2015. Electroencephalography and Evoked Potentials: Technical Background. Clinical Neurophysiology in Disorders of Consciousness. Springer. 7-23.
- 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.
Esmael Ahmed, MD principal investigator
Assistant Prof of Neurology
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 Myoclonus and Evoked Potential, run by Mansoura University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory evoked potential (time frame: 24-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235452, which also lists 3 linked publications.
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 22 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.