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

NCT ID: NCT03551431

Last Updated: 2018-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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EEG, Psychogenic Non Epileptic Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open labeled, randomized controlled Non-inferiority study with three parallel arms: video EEG with verbal suggestion only, cotton swab with verbal suggestion and tuning fork along with verbal suggestion
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Video EEG with verbal suggestion

Group Type EXPERIMENTAL

Video EEG with verbal suggestion

Intervention Type DIAGNOSTIC_TEST

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.

video EEG with verbal suggestion and tuning fork

Group Type EXPERIMENTAL

Video EEG with verbal suggestion

Intervention Type DIAGNOSTIC_TEST

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.

video EEG with verbal suggestion and cotton swab

Group Type EXPERIMENTAL

Video EEG with verbal suggestion

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sheffali Gulati

Professor and Chief, Child Neurology Division, Department of Pediatrics, AIIMS, New Delhi

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sheffali Gulati, MD Pediatrics

Role: CONTACT

011-26594679

Other Identifiers

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Induction

Identifier Type: -

Identifier Source: org_study_id

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