| CTRI Number |
CTRI/2018/10/015888 [Registered on: 03/10/2018] Trial Registered Prospectively |
| Last Modified On: |
27/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment during seizures |
|
Scientific Title of Study
|
Customized vs regular testing battery during ictal phase in lateralizing and localizing seizures in epilepsy monitoring unit (EMU) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sura Pradeep Kumar Reddy |
| Designation |
MBBS MD |
| Affiliation |
AIIMS |
| Address |
Neurosciences Centre, Department of Neurology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
7406511720 |
| Fax |
|
| Email |
reddy3430@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
MBBS DM |
| Affiliation |
AIIMS |
| Address |
Room No. 705, Neurosciences Centre, Department of Neurology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
mtripathiaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sura Pradeep Kumar Reddy |
| Designation |
MBBS MD |
| Affiliation |
AIIMS |
| Address |
Neurosciences Centre, Department of Neurology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
7406511720 |
| Fax |
|
| Email |
reddy3430@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical Sciences |
| Address |
AIIMS, Ansari Nagar east, South Delhi, PIN 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SURA PRADEEP KUMAR REDDY |
AIIMS |
Video EEG Lab, NS4 Ward, 4th floor Neurosciences Centre, Department of Neurology
South
DELHI |
7406511720
reddy3430@gmail.om |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECPG-AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized testing battery |
Structured customized testing battery will be used in assessment of patient during ictal phase of the seizure in epilepsy monitoring unit. |
| Comparator Agent |
Regular testing battery |
Regular testing battery whatever being practiced in epilepsy monitoring unit will be used in testing patients during ictal phase of seizure |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in epilepsy monitoring unit (EMU).
Age more than 6 years
Temporal and extratemporal lobe epilepsies admitted for presurgical evaluation.
Baseline normal comprehension
|
|
| ExclusionCriteria |
| Details |
Patients having severe mental retardation.
Patient with significant non- neurological co-morbidities like chronic cardiac, renal and other systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of clinical localisation as per assessment by using customised testing battery with MRI brain and EEG. |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility of the battery in clinical practice. |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Video-eletroenecphalography monitoring is a useful diagnostic tool that provides detailed electro-clinical information to characterise seizures for accurate diagnosis and classification of patients with epilepsy. Assessment during ictal phase is an important aspect as it helps in characterizing various cognitive, behavioural, sensory and motor functions. Epilepsy monitoring unit (EMU) staff should have a simple battery wherein they can easily assess and categorize the seizure type. Till date there is no standardized testing battery to assess patients during ictal phase of the seizure so we would like to develop a comprehensive testing battery which will be useful in lateralising and localising seizures.
|