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CTRI Number  CTRI/2019/08/020905 [Registered on: 26/08/2019] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Recovery of power by stimulation of spinal cord after Spinal Cord Injury: A pilot clinical study 
Scientific Title of Study   Motor Recovery by Epidural stimulation after Spinal Cord Injury: A pilot clinical study 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
ISIC/RP/2018/090  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harvinder Singh Chhabra 
Designation  Medical director and Chief of Spine Service,ISIC 
Affiliation  spine surgery 
Address  Indian Spinal Injuries Center, Sector-C,Vasant Kunj,New Delhi

South
DELHI
110070
India 
Phone  9597732908  
Fax    
Email  drhschhabra@isiconline.org  
 
Details of Contact Person
Scientific Query
 
Name  DrKalyan Kumar Varma 
Designation  Spine Fellow 
Affiliation  indian spinal injuries center 
Address  Indian Spinal Injuries Center sector c opposite Vasant Valley school vasant kunj new delhi 110070
dr kalyan kumar varma kalidindi indian spinal injuries center sector c opposite vasant valley school vasant kunj new delhi 110070
South
DELHI
110070
India 
Phone  9849923607  
Fax    
Email  kalyanvarmambbs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKalyan Kumar Varma 
Designation  Spine Fellow 
Affiliation  indian spinal injuries center 
Address  Indian Spinal Injuries Center sector c opposite Vasant Valley school vasant kunj new delhi 110070
dr kalyan kumar varma kalidindi indian spinal injuries center sector c opposite vasant valley school vasant kunj new delhi 110070
West
DELHI
110070
India 
Phone  9849923607  
Fax    
Email  kalyanvarmambbs@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Center 
 
Primary Sponsor  
Name  Indian Spinal Injuries Center 
Address  sector-C,Vasant Kunj,New Delhi 
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 
DrKalyan Kumar Varma  Indian Spinal Injuries Center  sector c opposite vasant valley school vasant kunj new delhi 110070
South
DELHI 
9597732908

kalyanvarmambbs@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S220||Fracture of thoracic vertebra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural Stimulation  Subjects will be implanted with an epidural stimulator once for continuous stimulation onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation. 
Comparator Agent  Physical Rehabilitation  Patients undergo a standard rehabilitation programme. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping with body weight support training
No current anti-spasticity medication regimen
Non-progressive spinal cord injury between the vertebral levels of C5 & T12
American Spinal Injury Association grading scale of A/B/C
Sensory evoked potentials are either not present or have a bilateral delay
At least 6 months post-injury 
 
ExclusionCriteria 
Details  Pregnancy at the time of enrollment
Failure to obtain consent
Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with a stand or step training
Current anti-spasticity medication regimen
Implanted cardiac pacemaker
Implanted defibrillator
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1,Improvement in the AIS of at least one grade (for example, conversion from AIS A to AIS B or better) or a change from baseline of 6 points in total ASIA motor score.
 
1,Improvement in the AIS of at least one grade (for example, conversion from AIS A to AIS B or better) or a change from baseline of 6 points in total ASIA motor score.
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in ASIA sensory examination
Any voluntary movement by additional muscle groups not included in ISNCSCI
Walking Index of Spinal Cord Injury (WISCI)
Modified Ashworth Spasticity Scale
Spinal Cord Independence Measure (SCIM)
Psychological evaluation by Beck Depression Inventory (BDI)
Electromyography (EMG), nerve conduction velocity (NCV), somatosensory evoked potential (SSEP) and motor-evoked Potential (MEP),
Urodynamic study
International Spinal Cord Injury Scale (ISCIS) 
two years 
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
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)   30/09/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Spinal cord injury (SCI) is often a catastrophic condition requiring chronic care. Despite an enormous amount of research in SCI, the neurological prognosis for a patient with severe SCI remains dismal. Furthermore, majority of the patients with SCI are young, and the economic and societal impact is enormous, both to the immediate family and the society at large. Life expectancy after such an injury is markedly reduced due to complications proportional to the severity of injury or remaining neurologic functions. A number of surgical modalities are available for traumatic conditions of spine. Despite having good radiological results, their impact on socioeconomic status of an individual in developing nations poor. One of the reasons for such a condition is non-functional improvement in motor power after traumatic SCI surgery.

Previous studies conducted in animal models, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. A few human studies in western world have shown epidural electrical stimulation of the lumbosacral spinal cord in spinal cord injury (SCI) was able to partially restore motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore motor and autonomic functions in patients with SCI.

 
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