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CTRI Number  CTRI/2024/10/076089 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to determine the cognitive impairment in persons with drug resistant epilepsy on Anti Seizure Medications. 
Scientific Title of Study   Cognitive impairment in persons with drug resistant epilepsy and correlation with homocysteine, pyridoxine, folic acid, cyanocobalamine and BDNF levels. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jatinder Katyal 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences New Delhi  
Address  Lab no. 4018, Department of Pharmacology All India Institute of Medical Sciences East Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  01126593282  
Fax    
Email  jatinderkatyal.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatinder Katyal 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences New Delhi  
Address  Lab no. 4018, Department of Pharmacology All India Institute of Medical Sciences East Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  01126593282  
Fax    
Email  jatinderkatyal.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jatinder Katyal 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences New Delhi  
Address  Lab no. 4018, Department of Pharmacology All India Institute of Medical Sciences East Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  01126593282  
Fax    
Email  jatinderkatyal.aiims@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  All India Institute of Medical Sciences, East Ansari Nagar, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjari Tripathi  All India Institute of Medical Sciences New Delhi  Neurology OPD, Ground Floor, Cardio Neuro Centre Building, AIIMS, New Delhi
South
DELHI 		 01126594494

manjari.tripathi@gmail.com 
Dr Jatinder Katyal  All India Institute of Medical Sciences New Delhi  4018, Dept. of Pharmacology Teaching Block , AIIMS, New Delhi
South
DELHI 		 01126546472

jatinderkatyal.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  75.00 Year(s)
Gender  Both 
Details  1. Persons with Drug Resistant Epilepsy diagnosed as per ILAE criteria
2. Subjects willing to participate and able to provide written informed consent.
3. Subjects with basic understanding of Hindi or English.  
 
ExclusionCriteria 
Details  1. Participants who are unwilling to participate and do not provide written informed consent.
2. Alcohol consumption.
3. Pregnant and lactating women.
4. History of other chronic communicable/ noncommunicable, medical illness.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Neurocognitive assessment using Montreal cognitive assessment (MoCA)scale, Addenbrooke’s Cognitive Examination-III (ACE-III) Scale, Mini-Mental State Examination (MMSE) Scale
and MINI cognition scale.
Serum biomarkers for BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine. 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess domain wise cognitive impairment  During statistical analysis 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   01/12/2024 
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="2"
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   Cognitive decline is a major disability comorbidity in persons with epilepsy. This is particularly true in patients with drug epilepsy on multiple anti seizure drugs. It has been hypothesised that neuroinflammation can be a contributor to epilepsy development, as well as epilepsy related comorbidities. Besides inflammatory pathways, other potential causes are oxidative stress, hyperhomocysteinemia , and BDNF.  Hyperhomocysteinemia leads to the development of neurotoxicity. BDNF is an important regulatory protein in neurodevelopment, synaptogenesis and neurogenesis. Altered BDNF and homocysteine levels can be causative factors in refractory seizures and cognitive decline. Since group B vitamins like pyridoxine, folic acid and cyanocobalamine are cofactors for homocysteine metabolism, disturbance in homocysteine will be associated with changes in their levels. These can serve as potential targets for therapeutic intervention. 
This study is planned to explore the extent of cognitive impairment in persons with drug resistant epilepsy on anti-seizure drugs, as well as correlation with BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine. Eligible participants will be enrolled for the study on the basis of inclusion and exclusion criteria. Participants will undergo cognitive evaluation to assess cognitive domains using cognitive assessment scales like MoCA, ACEIII, MMSE and MINI. Also, blood samples of the participants will be taken for the estimation of BDNF, homocysteine, pyridoxine, folic acid and cyanocobalamine. These will then be correlated with cognitive impairment using statistical tools.
 
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