| CTRI Number |
CTRI/2024/11/077261 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vagus Nerve Stimulation In Patients Of Chronic Migraine |
|
Scientific Title of Study
|
Effect Of Vagus Nerve Stimulation On Headache And Heart Rate Variability In Patients Of Chronic Migraine |
| 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 Samiksha Rana |
| Designation |
MD student |
| Affiliation |
ESIC Medical college and Hospital , Faridabad |
| Address |
Department of physiology
ESIC medical college and hospital
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
08076747169 |
| Fax |
|
| Email |
drsamiksha25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Pandey |
| Designation |
Director Professor |
| Affiliation |
ESIC Medical college and Hospital , Faridabad |
| Address |
Department of physiology
ESIC medical college and hospital
Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
7042918222 |
| Fax |
|
| Email |
drpandeyak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samiksha Rana |
| Designation |
MD student |
| Affiliation |
ESIC Medical college and Hospital , Faridabad |
| Address |
Department of physiology
ESIC medical college and hospital
Faridabad
HARYANA
121001
India |
| Phone |
08076747169 |
| Fax |
|
| Email |
drsamiksha25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multidisciplinary Research Unit of ESIC medical college and hospital ,NH3 NIT, Faridabad,haryana 121001 funded by Department of Health Research ,India |
|
|
Primary Sponsor
|
| Name |
Multidisciplinary Research Unit funded by Department of Health Research |
| Address |
ESIC medical college and hospital ,NH3 NIT, Faridabad
Haryana 121001
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrSamiksha Rana |
ESIC medical college and hospital,Faridabad |
Academic block
Physiology Department
3rd floor,AFT lab
Faridabad
HARYANA |
8076747169
drsamiksha25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of ESIC medical college and Hospital,Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
transcutaneous auricular non-invasive Vagus nerve stimulation |
transcutaneous auricular non-invasive Vagus nerve stimulation device from Soterix Medical hand-held Electrical Stimulation Solutions will be used to give stimulation in left ear twice a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed case of chronic migraine without aura and on pharmacological prophylaxis for the past 3 months.
the patient should be able to provide informed consent for using the ta-VNS device and self-assessment scale. |
|
| ExclusionCriteria |
| Details |
History of Neurological disorder, cardiovascular disease, CVA, asthma, or any other co-morbidity that may cause sudden death.
The patient is known to have auricular trauma or surgery that may affect the application of the ta-VNS device.
Has uncontrolled high blood pressure, and a history of syncope or seizures.
It is currently implanted with an electrical or neuro-stimulatory device.
Has a history of substance abuse.
Is pregnant or planning conception in the next three months.
Is a participant in any other therapeutic clinical investigation or clinical trial in the preceding 30 days.
Has a condition that compromises his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks |
decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect on Heart Rate Variability at 6 weeks |
effect on Heart Rate Variability at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsamiksha25@gmail.com].
- For how long will this data be available start date provided 16-01-2027 and end date provided 16-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Migraine is a common and debilitating neurological disorder, often causing significant disability, particularly in young women. Chronic migraine (CM), defined as headaches occurring 15 or more days per month with migraine characteristics on at least 8 days, affects about 1-2% of the global population. Despite treatment options such as triptans and prophylactic therapies like beta-blockers and Onabotulinum toxin-A, treatment efficacy remains suboptimal, and many patients experience medication overuse headaches. This has led to interest in non-pharmacological treatments, such as transcutaneous auricular non-invasive vagus nerve stimulation (ta-nVNS), which has shown promise in reducing the frequency and severity of migraines. The proposed study aims to assess the efficacy of ta-nVNS in both the prevention and management of chronic migraine, specifically focusing on headache frequency, duration, and heart rate variability (HRV), a marker of autonomic dysfunction associated with migraine. Patients diagnosed with chronic migraine will receive ta-nVNS treatment twice weekly for six weeks. The study will also record HRV as a secondary outcome to assess autonomic function changes. The findings could provide valuable insights into the role of ta-nVNS in migraine management, particularly in under-researched populations such as those in India. |