| CTRI Number |
CTRI/2025/08/093623 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of magnetic resonance in evaluation of epilepsy in adult population |
|
Scientific Title of Study
|
Role of MRI and MR spectroscopy in evaluation of epilepsy in adult population |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasad Sanjay Desale |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Radio-diagnosis, Ground Floor, A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA
442001
India
Wardha MAHARASHTRA 442001 India |
| Phone |
9423192054 |
| Fax |
|
| Email |
99radangel@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajasbala Dhande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Radio-diagnosis, Ground Floor, A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA
442001
India
Wardha MAHARASHTRA 442001 India |
| Phone |
9822239238 |
| Fax |
|
| Email |
dhanderajas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajasbala Dhande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Radio-diagnosis, Ground Floor, A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA
442001
India
MAHARASHTRA 442001 India |
| Phone |
9822239238 |
| Fax |
|
| Email |
dhanderajas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, India - 442001
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Wardha 442001, Maharashtra |
| Type of Sponsor |
Private 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 |
| Dr Prasad Desale |
Datta Meghe Institute of Higher Education and Research |
Department of
Radio-diagnosis,
Ground floor ,
A.V.B.R.H building,
Sawangi, Meghe.
Wardha
MAHARASHTRA Wardha MAHARASHTRA |
9423192054
99radangel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients aged 18-80 years present to the Department of Radio Diagnosis for an MRI scan to evaluate seizures.
2.Patients are presenting with new-onset seizures.
3.Patients presenting with refractory seizures.
|
|
| ExclusionCriteria |
| Details |
1.Patients with age below 18 years.
2.Patients presenting with Syncopal & hypoglycemic attacks or drug-induced seizures.
3.Patients presenting with Trauma-induced seizures.
4.Patients with a previous history of neurosurgery.
5.Patients with known contraindications to MRI.
6.Patients not willing for examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the range of MRI result in the adult population with seizures is expected. To examine the MR spectroscopy findings in patients with epilepsy & the role of MR spectroscopy in evaluating MRI-negative causes of epilepsy.
|
outcome will be determined after 1 year after starting the trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
08/09/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abstract: The groundbreaking development of MRI for seizure
assessment has been a huge boon for the clinical care of individuals with
neurologic problems & detecting brain abnormalities. The localization of
structural & functional changes has also been accomplished by co-registering
MRI with other functional imaging modalities. Objective: To Identify Potential Causes of Seizures in Adult
Population using Magnetic Resonance Imaging & Spectroscopy. Methodology: Cross-sectional
analytical research was done at the “Department
of Radio-diagnosis, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute
of Medical Sciences, Sawangi (Meghe), Wardhaâ€, among
100 adult patients presenting with seizures. Every patient had a thorough,
in-depth history-taking process, a normal general physical examination, & a
history of drug or contrast media reactions. The subjects were briefed on the
specifics of the study protocol, including the dangers of contrast imaging. Results: After appropriate statistical
evaluation, we anticipate to find the range of MRI investigation in the adult
population with seizures. To examine the MR spectroscopy findings in patients
with epilepsy & the role of MR spectroscopy in evaluating MRI-negative
causes of epilepsy. Conclusion: We plan to examine the range of
MRI results associated with neoplasms, infections, developmental disorders, &
vascular conditions in this investigation.
to investigate MRI as a noninvasive, radiation-free technology that
offers superior gray-white matter resolution, multiplanar imaging capacity, &
increased sensitivity & specificity for seizure evaluation. |