NCT04235452

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 16, 2020

Last Update Submit

January 16, 2020

Conditions

MyoclonusEvoked Potential

Keywords

Myoclonus, Evoked potential

Outcome Measures

Primary Outcomes (1)

  • 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.

    24-72 hours

Study Arms (2)

Epileptic myoclonus

Juvenile Myoclonic Epilepsy and Progressive Myoclonic Epilepsy

Diagnostic Test: Somatosensory evoked potential

Non-epileptic myoclonus (secondary)

Post hypoxic myoclonus, Post ischemic stroke myoclonus, Hepatic, Chronic kidney disease, and Drug induced myoclonus

Diagnostic Test: Somatosensory evoked potential

Interventions

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.

Epileptic myoclonusNon-epileptic myoclonus (secondary)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patients with myoclonus of different etiologies (primary and secondary myoclonus).

You may qualify if:

  • Myoclonus classified into primary and secondary myoclonus.

You may not qualify if:

  • Psychiatric comorbidity to exclude psychological myoclonus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 20057497RESULT

  • Agarwal P, Frucht SJ. Myoclonus. Curr Opin Neurol. 2003 Aug;16(4):515-21. doi: 10.1097/01.wco.0000084231.82329.9c.

    PMID: 12869812RESULT

  • Alvarez, V. & Rossetti, A. O. 2015. Electroencephalography and Evoked Potentials: Technical Background. Clinical Neurophysiology in Disorders of Consciousness. Springer. 7-23.

    RESULT

MeSH Terms

Conditions

Myoclonus

Interventions

Evoked Potentials, Somatosensory

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Esmael Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 22, 2020

Study Start

November 1, 2018

Primary Completion

August 31, 2019

Study Completion

October 31, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)