| CTRI Number |
CTRI/2024/08/072404 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Assess The Effect Of Preoperative Transcranial Magnetic Stimulation On Post Surgical Pain After Breast Surgery |
|
Scientific Title of Study
|
To Assess The Effect Of Preoperative Repititive Transcranial Magnetic Stimulation On Post Mastectomy Pain Syndrome: A Randomised Control 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 |
Dr Yukti Sharma |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DrBRA IRCH AIIMS Campus Ansari Nagar East New Delhi Delhi
New Delhi
DELHI
110029
India |
| Phone |
8054892551 |
| Fax |
|
| Email |
yuktis14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishkarsh Gupta |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DrBRA IRCH AIIMS Campus Ansari Nagar East New Delhi Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Nishkarsh Gupta |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DrBRA IRCH AIIMS Campus Ansari Nagar East New Delhi Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013310014 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
DrBRA IRCH AIIMS Campus Ansari Nagar East New Delhi
Pin code - 110029 |
| 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 |
| DR Yukti Sharma |
Operation theatre 6th floor, ALL INDIA INSTITUE OF MEDICAL SCIENCES NEW DELHI |
DrBRA IRCH AIIMS Campus Ansari Nagar East New Delhi Delhi
New Delhi
DELHI |
8054892551
yuktis14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention group - Repetitive transcranial magnetic stimulation (rTMS) |
Repetitive transcranial magnetic stimulation (rTMS) is non-invasive brain stimulation.
Patients will receive 20-minute sessions of either real or sham therapy as per group allocation.
Intervention Group Protocol: Active rTMS group:
rTMS will be administered through a Neurosoft (Neuro MS/D) TMS machine, housing an angled and cooled figure-of-8 coil (F8), strategically positioned over the Dorsolateral Prefrontal Cortex (DLPFC) on right side. We will apply rTMS therapy with parameters akin to established protocols - 90% resting motor threshold (RMT), a frequency of 1 Hz, and 1200 pulses per session (comprising 20 trains of pulses, with a 60-second interval) delivered over five consecutive days.
To ensure precision, we will mark the ideal coil position on the scalp, guided by surface anatomy references and RMT records. We will employ a single TMS pulse to elicit a minimal visible contraction in Abductor Pollicis Brevis (APB) of non-target extremity in at least 5 out of 10 pulses to determine M1 hotspot.
An articulated support will securely hold the coil, tangentially oriented to the interhemispheric fissure, ensuring that participants can distinctly perceive the coil noise.
|
| Comparator Agent |
Sham group - Repetitive transcranial magnetic stimulation (rTMS) |
Patients will receive 20-minute sessions of either real or sham therapy as per group allocation.
Sham Group Protocol:
The credibility of the study depends on the development of a highly believable sham treatment. In the sham therapy group, we will utilize the same F8 coil, albeit elevate and tilt away from the head to simulate rTMS therapy sessions without inducing any current in the brain. Crucially, as none of the patients will have prior exposure to rTMS, they will remain unaware of the tactile sensation associated with active stimulation.
Within 7 days of completion of 5 sessions of rTMS/ sham therapy, patient will be posted for surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18-70 years,
2. American Society of Anaesthesiologists (ASA) physical status I-III,
3. Scheduled for elective surgery for breast cancer (unilateral surgical procedure with or without axillary lymph node dissection).
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal,
2. Contraindications to transcranial magnetic stimulation:
iii. Patients who have ferromagnetic or magnetic sensitive metal objects implanted in the head or neck areas in close proximity to the TMS coil magnetic fields.
iv. Surgical placement of medical devices (eg, metal plates, clips, electrodes, chips, pumps, stimulators, cochlear implants, pacemakers), as well as past exposure to all metal fragments, tattoos rendered with ferromagnetic-containing ink, permanent piercings, and/or other possible metal sources in the head and neck.
3. Neurological or psychiatric disorders, concurrent major depression,H/o head trauma
4. History of substance abuse,
5. ASA-PS IV or more,
6. History of Head trauma.
|
|
|
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 |
| To assess the reduction in incidence of PMPS using SF-MPQ and EQ-5D-3L questionnaire. |
at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include assessment of postoperative opioid consumption up to 24 hrs and postoperative pain assessment up to 24 hours using Numeric Pain Rating Scale (NRS). |
up to 24 hours in post-operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| Date of Study Completion (India) |
01/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| B Breast carcinoma is the most common malignancy in the world. Surgical removal is main stay of treatment for early-stage breast. One of the postoperative complications is persistent pain which accounts for incidence up to 68 % in mastectomy patients.
Post-mastectomy pain syndrome (PMPS) is a persistent neuropathic pain in the chest, axilla, shoulder, or upper arm for over three months after surgery.
Repetitive transcranial magnetic stimulation (rTMS) is non-invasive brain stimulation method which has been developed recently used for the treatment of psychiatric and neurological disorders which has shown to provide significant analgesia in patients of neuropathic pain of various causes.
We hypothesise that rTMS will reduce immediate postoperative pain and subsequently reduce the incidence of PMPS in patients undergoing chemotherapy. So we have planned this randomised control trial with the primary objective to assess the effect of rTMS on PMPS in patients undergoing modified radical mastectomy under general anaesthesia and to provide clinical evidence for rTMS therapy in reducing the incidence of PMPS.
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