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CTRI Number  CTRI/2024/07/071057 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of 10Hz rTMS as an adjunctive to pregabalin in addition to Pregabalin in Central Post Stroke Pain : A randomised double blind placebo controlled trial 
Scientific Title of Study   To compare the efficacy and tolerability of adjunctive high frequency rTMS plus pregabalin over pregabalin alone in patients with CPSP: A randomized double- blind cross over trial in single-center tertiary care referral teaching hospital. 
Trial Acronym  RTMS-CPSP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  05222494177  
Fax    
Email  jayanteek@yahoo.com  
 
Source of Monetary or Material Support  
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, Uttar Pradesh, India-226014 
 
Primary Sponsor  
Name  Professor Jayantee Kalita 
Address  Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli road, Lucknow, Uttar Pradesh, India-226014 
Type of Sponsor  Other [Self] 
 
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 
Professor Jayantee Kalita  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, Uttar Pradesh, India-226014
Lucknow
UTTAR PRADESH 
05222494177

jayanteek@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High frequency repetitive transmagnetic stimulation(rTMS)   3 sessions of monthly HF rTMS for 3 consecutive days in each session followed by cross over to another group. Total duration of study is 8 months 
Comparator Agent  Pregabalin  Pregabalin given to both groups in dose of 75mg BD for 1 week followed by 150mg BD to continue through out the study being continued  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age more than 18 years, those fulfilling the diagnostic criteria of CPSP, pain intensity more than equal to 4 on a Visual analog scale (VAS, 0 to 10 with 0 indicating no pain and 10 the worst pain imaginable), those who will give the consent to participate in the study 
 
ExclusionCriteria 
Details  Age more than 70 years and less than 18 years, patients with less than 4 pain on VAS, epilepsy, pregnancy, metallic implant, pacemaker, painful peripheral neuropathy, complex regional pain syndrome, psychiatric and post‑head injury pain disorders, bony defect of scalp, chronic renal or liver failure, heart failure, cancer, and those with a history of drug allergy will be excluded. The patients with dementia and aphasia, and those who are not willing to give consent will also be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Greater than 50% reduction in pain on visual analog scale.  Baseline, 1 month and at 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in pain from baseline on visual analog scale (VAS)
2. Improvement in scores of Neuropsychiatric Inventory (NPI), Hospital anxiety depression
scale (HADS) score, Pittsburgh sleep quality index (PSQI), Quality of life index (QOL),
Median Somatosensory evoked potentials, Mechanical static, Mechanical dynamic
allodynia and Cold allodynia. 
baseline, 1 month and at 3 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   03/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/08/2024 
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 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  

Stroke is the second leading cause of death in the world . Among those who survive, motor and somatosensory sequelae compromise the functional capacity and quality of life in many individuals. In general, one candefine two types of pain after stroke: pain associated with peripheral mechanisms (e.g., musculoskeletal, spastic pain, headache, and shoulder pain) and neuropathic central post-stroke pain (CPSP) CPSP can be disabling and further impactson quality of life, quality of sleep and has been associated with depression, fatigue, anxiety, difficulties in cognitive function and physical activity. Various pharmacotherapies are 1. Antidepressants- Amitriptyline includes (Balanced monoamine reuptake inhibition) 2. Anticonvulsants- a) Phenytoin (Voltage-gated sodium-channel blockade) b) Carbamazepine (Voltage-gated sodium-channel blockade) c) Lamotrigine (Presynaptic voltage-gated sodium-channel inhibition thus reduced release of presynaptic transmitters) d) Topiramate (Voltage-gated sodium-channel block and inhibition of glutamate release by an action on AMPA/kinase receptors) e) Gabapentin (Binding to α2δ subunit of presynaptic voltage-dependent calcium channels with reduced release of presynaptic transmitters) f) Zonisamide (Voltage-gated sodium-channel block) 3. Anesthetics – a) Lidocaine (Blockade of sodium channels thus preventing ectopic discharges) b) Mexiletine (Same as lidocaine) 4. NMDA receptor antagonist - Ketamine 5. Analgesics- Tramadol and morphine (μ opioid-receptor agonist and monoamine Morphine Reuptake inhibitor). Non--pharmacological treatment includes– 1. Invasive motor cortex simulation 2. Deep brain stimulation (DBS) 3. Repetitive transcranial magnetic stimulation (rTMS) 4. Vestibulocochlear stimulation has been tried in patients with CPSP refractory to pharmacotherapy. rTMS is a noninvasive technique that stimulates specific cerebral cortex regions by inducing electrical currents through coils placed on the cranium. M1 is a possible rTMS therapy target for neuropathic pain. Multiple studies have demonstrated that high-frequency (5–20 Hz) rTMS of the motor cortex alleviates chronic pain . rTMS has been an upcoming non- invasive, non-pharmalogical treatment modality for a number of neurological and psychiatric diseases including stroke recovery, migraine, fibromyalgia, movement disorders like Parkinson’s disease, essential tremors, Obsessive compulsive disorder, major depressive disorder etc. However, Level A evidence (definite efficacy) was reached for: high-frequency (HF) rTMS of the primary motor cortex (M1) contralateral to the painful side for neuropathic pain. Level B evidence (probable efficacy) was reached for: HF-rTMS of the left M1 or DLPFC for improving quality of life or pain, respectively, in fibromyalgia. Level A/B evidence is not reached concerning efficacy of rTMS in any other condition. The efficacy of Pregabalin in a RCT vs placebo was and the efficacy of rTMS v/s placebo in a RCT (Quesada et al) was 33.3%. However, there is paucity of information about comparing the efficacy of rTMS and pregabalin in the treatment of CPSP. Inthis context, we would like to conduct this prospective study to compare rTMS + pregabalin versus pregabalin alone in the treatment of CPSP.

 

 
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