| CTRI Number |
CTRI/2025/12/099801 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial Magnetic stimulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of change in pain relief in subjects with neuropathic pain due to diabetes using magnetic stimulation applied across the scalp |
|
Scientific Title of Study
|
Effect of repetitive Transcranial magnetic stimulation for resistant diabetic neuropathic pain: A pilot study |
| 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 Rajeswari Aghoram |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132297285 |
| Fax |
|
| Email |
rajeswari.a@jipmer.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
BALAKUMAR J |
| Designation |
BSc Neurotechnology (Intern) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7339316222 |
| Fax |
|
| Email |
balakumarjayavel011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeswari Aghoram |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132297285 |
| Fax |
|
| Email |
rajeswari.a@jipmer.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry, India-605006. |
|
|
Primary Sponsor
|
| Name |
Dr Rajeswari Aghoram |
| Address |
Department of neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry. |
| 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 |
| Dr Rajeswari Aghoram |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Neurology, SSB, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry.
Pondicherry
PONDICHERRY |
0413 229 7285
rajeswari.a@jipmer.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Transcranial Magnetic Stimulation |
Repetitive pulse mode, Frequency 10Hz, Pulse per train 50, Number of trains 15, Pulse duration 5seconds, Interpulse duration 30seconds, Test duration 8 minutes 15 seconds, Coli type MCF-B70(butterfly coil), Number of days performed 5 days. Total duration Intervention is around 100 minutes/patient over 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetic patients with diabetic neuropathy as defined by toronto clinical neuropathy score more than 9 and resistant pain defined as visual analogue score in the last one week more than 4 while being on at least one pain relief medication. |
|
| ExclusionCriteria |
| Details |
a) Any active ulcer or inflammation
b) Any other cause that can explain the pain like fractures
c) Past history of seizure or epilepsy in self or family. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the change in Visual analogue score (VAS)
|
It will be estimated following 5 sessions of Repetitive Transcranial Magnetic Stimulation and also at the end of 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the change in visual analogue score at the end of 5 sessions, and at the end of 1 month and 2 month
|
Visual analogue score is estimated at end of 5 sessions, 1 month and 2 months |
| To evaluate safety and tolerability of repetitive transcranial magnetic stimulation in this patient population |
It will be estimated at end of 1 month |
| To evaluate its effect on nerve conduction parameters, Patient global impression of change and DN4 scale. |
Effect on Nerve conduction parameters will be estimated at end of 2 weeks, Patient global impression of change at end of 1 month and DN4 scale at end of 5 sessions, 2 weeks, 1 month and 2 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
05/01/2026 |
| 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="0"
Months="6"
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
|
Chronic pain is a disabling problem that is likely to increase in magnitude as the population ages. It has limited therapeutic options with only moderate efficacy and significant side effects. This study will provide initial data in the Indian context on the safety and efficacy of Repetitive transcranial magnetic stimulation as adjunct treatment in resistant painful diabetic neuropathy. If found safe and effective it can inform larger study to provide better evidence for this treatment modality and can also be expanded to include other chronic pain conditions. |