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
|
|
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
|
|
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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