EEG, Psychogenic Non Epileptic EventsNCT03551431
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
A study testing Video EEG with verbal suggestion in people with EEG, Psychogenic Non Epileptic Events, run by All India Institute of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- EEG, Psychogenic Non Epileptic Events
- What is being tested?
- Video EEG with verbal suggestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
-
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- EEG, Psychogenic Non Epileptic Events
- Being tested
- Video EEG with verbal suggestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video EEG with verbal suggestionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Video EEG with verbal suggestion | Experimental | Not described Receives: Diagnostic Test: Video EEG with verbal suggestion |
| video EEG with verbal suggestion and tuning fork | Experimental | Not described Receives: Diagnostic Test: Video EEG with verbal suggestion |
| video EEG with verbal suggestion and cotton swab | Experimental | Not described Receives: Diagnostic Test: Video EEG with verbal suggestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEG, Psychogenic Non Epileptic EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551431
- Sponsor's protocol ID
- Induction
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03551431
- Acronym / sponsor ID
- Induction
- Conditions
- EEG, Psychogenic Non Epileptic Events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Video EEG with verbal suggestion | Experimental | Diagnostic Test: Video EEG with verbal suggestion |
| video EEG with verbal suggestion and tuning fork | Experimental | Diagnostic Test: Video EEG with verbal suggestion |
| video EEG with verbal suggestion and cotton swab | Experimental | Diagnostic Test: Video EEG with verbal suggestion |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video EEG with verbal suggestionVideo 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. | Diagnostic test | Video EEG with verbal suggestion, video EEG with verbal suggestion and cotton swab, video EEG with verbal suggestion and tuning fork |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Video EEG with verbal suggestion in people with EEG, Psychogenic Non Epileptic Events, run by All India Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheffali Gulati, MD Pediatrics (011-26594679, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children in each group, in whom the paroxysmal event could be reproduced by suggestion (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.