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CTRI Number  CTRI/2025/06/089392 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Understanding Muscle Weakness and Nerve Function in Guillain-Barré Syndrome Using Blood Markers and Autonomic Tests 
Scientific Title of Study   Biomarkers and Autonomic Dysfunction in Sarcopenia Evaluation for Guillain-Barré Syndrome (BASE-GBS): A Prospective Cohort Study 
Trial Acronym  BASE-GBS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Suresh Naik 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences  
Address  Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore

Bangalore
KARNATAKA
560028
India 
Phone  9986308719  
Fax    
Email  neurodocms@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Shweta Suresh Naik 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences  
Address  Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore

Bangalore
KARNATAKA
560028
India 
Phone  9986308719  
Fax    
Email  neurodocms@gmail.com   
 
Details of Contact Person
Public Query  
Name  Shweta Suresh Naik 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences  
Address  Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical care National Institute of Mental Health and Neurosciences Hosur Main Road Bangalore

Bangalore
KARNATAKA
560028
India 
Phone  9986308719  
Fax    
Email  neurodocms@gmail.com   
 
Source of Monetary or Material Support  
Anusandhan National Research Foundation (ANRF) 4th Floor, AI Block, Technology Bhawan Complex, New Mehrauli Road, New Delhi-110016. 
 
Primary Sponsor  
Name  Shweta Suresh Naik 
Address  National Institute of Mental Health and Neurosciences Bangalore560029  
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shweta Suresh Naik  NIMHANS  No 21 Faculty Building Third Floor Department of Neuroanaesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences Hosur Main road Bengaluru Karnataka-560028
Bangalore
KARNATAKA 		 9986308719

neurodocms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Mental Health and Neurosciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G610||Guillain-Barre syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Adults aged 18-75 years with a confirmed diagnosis of GBS admitted in ICU.
2. Informed consent obtained from patients or their legal representatives.
 
 
ExclusionCriteria 
Details  1. Conditions causing sarcopenia independent of critical illness (e.g., advanced chronic kidney disease, liver disease). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the incidence and severity of sarcopenia in GBS patients using Body composition analysis
 		 day0,7,14 or discharge
 
 
Secondary Outcome  
Outcome  TimePoints 
2. To predict the incidence and severity of sarcopenia in GBS patients using ultrasound, markers of autonomic function and biochemical biomarkers.
 		 day0,7,14 or discharge 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   10/07/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This will be a  prospective observational study to be conducted in the intensive care unit to assess the incidence and severity of sarcopenia in adult patients diagnosed with Guillain-Barre Syndrome (GBS). The study aims to evaluate the role of autonomic dysfunction and biochemical biomarkers in predicting sarcopenia and its clinical impact. Body composition will be assessed using ultrasound and functional tests. Autonomic function will be evaluated using bedside tests and pupillary response. Blood samples will be collected to measure nutritional and inflammatory markers. The study will also explore the association between sarcopenia and clinical outcomes such as ICU stay and hospital stay. The goal is to develop a predictive framework for early identification and risk stratification of sarcopenia in critically ill GBS patients. 
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