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CTRI Number  CTRI/2025/03/083241 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Repetitive Transcranial Magnetic Stimulation ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing high versus low frequency rTMS for neuropathic pain in spinal cord injury patients 
Scientific Title of Study   A study to compare efficacy of high versus low frequency rtMS on Dorsolateral prefrontal cortex in neuropathic pain management among patients with spinal cord injury : A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuj Patel 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Physical Medicine and Rehabilitation, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9977983778  
Fax    
Email  anujpatel@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Gita Handa 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dept. of Physical Medicine and Rehabilitation, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9899664489  
Fax    
Email  drgita.pmr@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Gita Handa 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Dept. of Physical Medicine and Rehabilitation, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9899664489  
Fax    
Email  drgita.pmr@aiims.edu  
 
Source of Monetary or Material Support  
AIIMS New Delhi, Ansari Nagar east, South Delhi, Delhi, India 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Ansari Nagar East, South Delhi, Delhi - 110029 
Type of Sponsor  Government medical college 
 
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 Anuj Patel  All India Institute of Medical Sciences, New Delhi  Room No 1, Ground floor, Department of Physical Medicine and Rehabilitation, In front of Amrit Pharmacy Gate No 2 , AIIMS New Delhi, Ansari Nagar East, South Delhi, Delhi, India 110029
South
DELHI 		 9977983778

anujpatel@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE EHTICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M792||Neuralgia and neuritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Frequency rTMS   Magnetic stimulation will be provided using Neurosoft MS/MD stimulator with angulated figure of 8 coil. Each patient will receive stimulation once per day for 5 days a week for two weeks (total 10 sessions). DLPFC will be the target site. By taking measurements 5 cm anterior and in a parasagittal line from the hand motor brain area, the left Dorsolateral prefrontal cortex rTMS stimulation site will be identified. The intensity will be set at 110% of the resting motor threshold in the rTMS group.It will be consisting of 25 trains of 5 seconds with inter-train interval of 25 seconds with total 1250 pulses delivered at a frequency of 10 Hz, with total duration of 12.5 minutes.  
Intervention  Low Frequency rTMS  It will also be given for 5 days a week for two weeks (total 10 sessions) and will be consisting of 50 trains of 25 seconds with inter-train interval of 2 seconds with total 1250 pulses delivered at a frequency of 1 Hz, with total duration of 22.5 minutes. 110% resting motor threshold will be used as the rTMS stimulation intensity.  
Comparator Agent  Sham rTMS  Sham stimulation will also be provided for 5 days a week for 2 weeks (total 10 sessions) and will be similar in noise production and beeps as rTMS group but the magnetic coil will be disconnected from the power source. It will be given for similar duration to either high or low frequency rTMS.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Admitted Spinal cord injury patients to PMR ward or OPD, both traumatic and non traumatic.
Duration of injury at least 6 months from spinal cord injury.
Patients diagnosed with neuropathic pain.
Duration of injury of neuropathic pain more than 3 months.
Patients who are capable of or willing to give informed consent. 
 
ExclusionCriteria 
Details  Patients with any Intracranial metallic hardware such as electrodes, aneurysm clips or coils, stents and programmable ventriculoperitoneal shunts.
Patients with Implanted electronic device: cochlear implants, vagus nerve stimulators, pacemakers or implantable cardioverter defibrillators and spinal cord stimulators.
History of Vascular, traumatic, tumoral, Infectious brain lesion.
Patients not willing to give informed consent.
Patients with epilepsy or history of epilepsy. Patients with cognitive dysfunction who cannot cooperate.
Patients not having preserved visible voluntary muscle twitch in any hand in thenar muscles
Patients with unstable vital signs.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score  Pre and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
H reflex Parameters (H wave amplitude & latency, M wave amplitude & latency, H/M ratio)  Pre and Post intervention 
Quality of life using ISCoS QoL data set  Pre and Post intervention 
SF-MPQ-2   Pre and post intervention 
AIS  Pre and post intervention 
DASS- 21  Pre and Post intervetnion 
MAS  Pre and Post intervention 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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   Phase 3 
Date of First Enrollment (India)   02/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Neuropathic pain is a challenging complication of Spinal Cord Injury and current treatment options including pharmacological and non pharmacological interventions often fails to provide appropriate pain relief and are associated with undesirable side effects. rTMS has emerged as a promising non-invasive neuromodulation technique, with evidence suggesting its efficacy in modulating cortical excitability and alleviating neuropathic pain. This study compares high vs Low frequency rTMS for neuropathic pain in SCI patients, determining optimal frequency and examining depression relief as a confounding factor and using H-reflex parameters to quantify pain modulation. 
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