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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04235452
Other study ID # Mansoura University 11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date October 31, 2019

Study information

Verified date January 2020
Source Mansoura University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Myoclonus classified into primary and secondary myoclonus.

Exclusion Criteria:

- Psychiatric comorbidity to exclude psychological myoclonus.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Egypt Mansoura University Hospital Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Agarwal P, Frucht SJ. Myoclonus. Curr Opin Neurol. 2003 Aug;16(4):515-21. Review. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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