| 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
|
|
|
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
|
|
|
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.
|