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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03551431
Other study ID # Induction
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2018
Est. completion date May 2019

Study information

Verified date June 2018
Source All India Institute of Medical Sciences, New Delhi
Contact Sheffali Gulati, MD Pediatrics
Phone 011-26594679
Email sheffaligulati@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study we are going to compare efficacy between suggestion method during video EEG recording by verbal suggestion in isolation and verbal suggestion along with cotton swab or tuning fork for inducing the paroxysmal event in children aged 5 to 18 years with suspected psychogenic nonepileptic events. Still there is paucity of data regarding the optimum method for video EEG by suggestion for psychogenic nonepileptic events. We are planning to recruit 25 children aged 5 to 18 years in each of the three arms after taking informed consent from the guardian and then they will be subjected to video EEG by any one of the three suggestion methods.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: Children between 5 and 18 years of age with suspected diagnosis of psychogenic nonepileptic events -

Exclusion Criteria: Children with paroxysmal events, who will be later diagnosed as having epilepsy or movement disorder

Study Design


Related Conditions & MeSH terms

  • EEG, Psychogenic Non Epileptic Events

Intervention

Diagnostic Test:
Video EEG with verbal suggestion
Video EEG with verbal suggestion will be done by attaching EEG electrodes to the child along with verbals suggestion in isolation or verbal suggestion and tuning fork, verbal suggestion and cotton swab.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of children in each group, in whom the paroxysmal event could be reproduced by suggestion Percentage of children in each group, in whom the paroxysmal event could be induced by suggestion 30 minutes