Comparison of 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

June 7, 2018 updated by: Sheffali Gulati, All India Institute of Medical Sciences, New Delhi
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video EEG with verbal suggestion
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.
Experimental: video EEG with verbal suggestion and tuning fork
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.
Experimental: video EEG with verbal suggestion and cotton swab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of children in each group, in whom the paroxysmal event could be reproduced by suggestion
Time Frame: 30 minutes
Percentage of children in each group, in whom the paroxysmal event could be induced by suggestion
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Induction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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