| CTRI Number |
CTRI/2023/08/056150 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Non invasive brain stimulation to modulate impaired gait and bladder abnormalities in incomplete spinal cord injury patients |
|
Scientific Title of Study
|
A randomized controlled trial to evaluate the effect of intermittent theta burst stimulation on gait pathomechanics and urinary tract dysfunction in incomplete spinal cord injury patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman Jain |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Physiology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sumanjain10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Banerjee |
| Designation |
PhD scholar |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Physiology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
6290276465 |
| Fax |
|
| Email |
rohitphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Banerjee |
| Designation |
PhD scholar |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Physiology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
6290276465 |
| Fax |
|
| Email |
rohitphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology (DBT)
Address:
6th-8th Floor, Block 2 and 4th-5th Floor, Block 3 CGO Complex, Lodhi Road New Delhi - 110 003.India
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari nagar
New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Rohit Banerjee |
AIl India Institute of Medical Sciences |
Brain Stimulation lab (Room no. 2001)
Department of Physiology,
Teaching Block,2nd floor, Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
6290276465
rohitphysio96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Invasive Neuromodulation Techniques |
Intermittent theta burst stimulation on primary motor cortex (M1).
Dose: 5 days per weeks for 2 weeks |
| Comparator Agent |
Physical Rehabilitation |
1. Upper limb exercise regime:
Progressive Resisted Exercises: (using manual resistance, dumbbells, theraband etc.)
# Progression based on De-Lorme & Watkins principle at 50-80% RM
2. Lower limb exercises regime:
A. Stretching exercises
B. Mobilization exercises
C. Strengthening Exercises
D. Horizontal leg press
E. Body weight-supported squats
3. General body exercise Regime:
A. Balance exercises
B. Core muscle strengthening
C. Core-endurance training
D. Pelvic floor training
E. Gait training (parallel bar, over ground gait training in treadmill)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Spinal cord Injury (ASIA C or D)
Region: (Cervical C6 and C7), Thoracic and Lumbar Spine
Duration : ≤ 2 years
Type: Traumatic and Non-traumatic |
|
| ExclusionCriteria |
| Details |
Osteoporotic fractures, or other Pathological fractures.
History of neurological or orthopaedic disease related to spinal cord.
Congenital malformations (disorder of neuro lesions) pertaining to CNS or PNS.
Cardiac Pacemaker, DBS, spinal cord stimulator, baclofen pump or any ferromagnetic metallic implants close to the target stimulation area.
Ventilator dependent and tracheostomy patients.
Cognitive impairments.
Pregnancy.
History/family history of seizures.
Acute eczema/ bed sore under the target stimulation area.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc) |
Baseline and 4 weeks after completion of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Urodynamic parameters (Detrusor leak point pressure, Detrusor sphincter dyssynergia, Incontinence abdominal leak point pressure, Post-void residual volume etc.).
Electrophysiological parameters (Resting Motor Threshold, Active Motor Threshold, Motor Evoked Potential).
Functional parameters (Walking index for SCI II, Spinal Cord Independence Measure III).
Neurological parameters (ASIA impairment scale, Modified Ashworth Scale).
Psycho-social parameters (Beck Depression Inventory, State Trait Anxiety Inventory II).
|
Baseline and 4 weeks after completion of the intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/08/2023 |
| 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
|
Spinal cord injury is a serious condition that produce significant impairment in motor, sensory and autonomic functions. To manage spinal cord injury conventional treatment have been employed such as: pharmacological, surgical and rehabilitation etc., few novel treatment strategies are under investigation to expect a better recovery. Intermittent theta burst stimulation is one of such non-invasive neuromodulation technique. Impaired gait and neurogenic bladder are major consequences of spinal cord injury with fatal outcome but less commonly addressed in previous literature. We hypothesize that cortical application of intermittent theta burst stimulation will improve gait pathomechanics and neurogenic lower urinary tract dysfunction in incomplete spinal cord injury patients. |