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CTRI Number  CTRI/2020/12/029871 [Registered on: 17/12/2020] Trial Registered Prospectively
Last Modified On: 04/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Feasibility study 
Study Design  Single Arm Study 
Public Title of Study   Monitoring of sensation during the Neurosurgery 
Scientific Title of Study   A feasibility study on the use of subdural somatosensory evoked potential monitoring during detethering surgery.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Semparuthi A 
Designation  M.Sc Neurotechnology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  203 Neurophysiology lab Department of Neurology Super specialty building JIPMER 605006
Jipmer Campus Rd, Gorimedu, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8973214408  
Fax    
Email  Semparuthiyasothai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gopalakrishnan MS 
Designation  Professor of Neurosurgery 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Neurosurgery JIPMER 605006
Jipmer Campus Rd, Gorimedu, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9345141431  
Fax    
Email  gopalakrishnanms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Semparuthi A 
Designation  M.Sc Neurotechnology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  203 Neurophysiology lab Department of Neurology Super specialty building JIPMER 605006
Super specialty building, Jipmer Campus Rd, Gorimedu, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8973214408  
Fax    
Email  Semparuthiyasothai@gmail.com  
 
Source of Monetary or Material Support  
Intramural funding of Jawaharlal Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  jipmer, Dhanvadhri nagar , puducherry 06 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
semparuthi A  Jawaharlal Institute of Postgraduate Medical Education and Research  Neurosurgery Operation Theater, Department of Neurosurgery, Super specialty building Jipmer Campus , Puducherry, 605006
Pondicherry
PONDICHERRY 		 8973214408

Semparuthiyasothai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe jipmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q059||Spina bifida, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Patients with tethered cord syndrome, which can involve cases with myelomeningocele, lipomyelomeningocele, and lumbosacral split cord malformations, and these operations are usually done in children but can rarely be done in adults also. So the age group involved is generally below 12 years but can be done in any age group if the patients present late.
 
 
ExclusionCriteria 
Details  Patients with preexisting severe sensory loss with large pressure sores where the possibility of obtaining an SSEP is unlikely.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
use of subdural ssep in detethering surgeries  recording the sensory potential directly from the spinal cord during the time to surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility of the Somatosensory evoked potential during detethering surgery  During the time of detethering surgery 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   04/01/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In detethering surgery for tethered cord syndrome patients, damage to the neural structures is avoided by intraoperative monitoring of lower limb muscles, and perianal sphincter muscles by free running electromyography and, more rarely, with motor evoked potentials. However the sensory nerves or the sensory part of the neural placode containing the conus medullaris are not monitored and could be damaged during the surgical procedure. Sensory evoked potential monitoring of the perianal region and the lower limbs were not considered useful during detethering surgery though technically possible. Recently there has been a report of a novel method monitoring the SSEP directly over the spinal cord and we would like to replicate the study in our setting and measure the amplitude and latency during the procedure.

 
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