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CTRI Number  CTRI/2024/10/076073 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Effects of neuromodulation device in patients suffering from migraine 
Scientific Title of Study   A Phase IV Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Nerivioâ„¢, a Neuromodulation Device, for the acute treatment of episodic and chronic Migraine.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DRL-NEU-002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Esha Singh  
Designation  Team Lead- Meical and clinical research services 
Affiliation  Mediception Science Pvt Ltd 
Address  Unit 711 & 817 Vipul Business Park Sector 48

Gurgaon
HARYANA
122018
India 
Phone  9264443445  
Fax    
Email  esha@mediception.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shende Shrikrishna 
Designation  Medical Innovation Lead 
Affiliation  Dr. Reddy’s Laboratories Limited 
Address  Dr. Reddy’s Laboratories Limited, Office no. 3 (Opposite to GG India office), 08th Floor, B-Block, ISprout, Divyasree Trinity, Plot No 5 & 6, Hitech City Rd

Hyderabad
TELANGANA
500081
India 
Phone  7066335999  
Fax  --  
Email  shrikrishnas@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Punit Srivastava 
Designation  Chief Scientific Officer 
Affiliation  Mediception Science Pvt Ltd. 
Address  Unit 711 & 817, Vipul Business Park Sector 48

Gurgaon
HARYANA
122018
India 
Phone  08586928449  
Fax    
Email  punit@mediception.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Limited Office no. 3 (Opposite to GG India office), 08th Floor, B-Block, ISprout, Divyasree Trinity, Plot No 5 & 6, Hitech City Rd, Madhapur, Telangana-500081 India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  8-2-337, Road No. 3, Banjara Hills Hyderabad Ranga Reddy Telangana - 500034  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagar Betai   Ansa Clinic  Department of Neurology, Block M, Mondeal Business Park, Near Gurudwara, S.G. Highway, Thaltej, Ahmedabad, 380054
Ahmadabad
GUJARAT 		 9904403142

drsagarbetai@gmail.com 
Dr Murali Krishna  BBR super specialty hospital  Department of Neurology,7-4-194 Ferozguda Balanagar Hyderabad
Hyderabad
TELANGANA 		 09347949209

drkmk3@gmail.com 
Dr Shiva Kumar R  Dr Shivas Neuron Clinics  Department of Neurology, Opposite Intel, Outer Ring Road, Marathahalli, Bangalore, Karnataka- India, 560103
Bangalore
KARNATAKA 		 9972487166

drshivakumar1995@yahoo.co.in 
Dr SK Chaudhary  Dr. Choudharys Neuro Clinic  Department of neurology, D-683 Ground Floor C R Park, New Delhi - 110019
South
DELHI 		 09811192873

skcneuro@gmail.com 
Dr Ramesh Patankar   Dr. Patankars Neuroclinic   Department of Neurology, Plot No 42 Rd No 15 Chembur Gaothan
Mumbai
MAHARASHTRA 		 9820148845

patrameshneuro@yahoo.co.in 
Dr Saurabh Bansal  Fortis memorial research institute  Department of neurology, Tower A, Unitech Business Park, Block - F, South City 1, Sector - 41, Gurgaon, Haryana - 122001
Gurgaon
HARYANA 		 7528910202

saurabh.bansal@fortishealthcare.com 
Dr Venkatraman  Kauvery hospital  Department of neurology, 81 TTK Road Junction, CIT Colony Alwarpet Chennai Tamil Nadu 600018
Chennai
TAMIL NADU 		 9597748201

dr.kvraman24@gmail.com 
Dr Subhash Kaul  KIMS (Krishna Institute of Medical Sciences) Hospital  Department of neurology, Begumpet, 1-8-31/1, Minister Rd, Krishna Nagar, Ramgopalpet, Secunderabad
Hyderabad
TELANGANA 		 9618848360

subashkaul@hotmail.com 
De Pratik Uttarwar  KIMS-Kingsway Hospitals 44  Department of Neurology Parwana Bhavan, Kingsway Rd Near Kasturchand Park, Nagpur, Maharashtra 440001
Nagpur
MAHARASHTRA 		 9179288227

pratikuttarwar1@gmail.com 
Dr Tushar Raut  Kokilaben Hospital  Department of neurology, Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA 		 9930087434

tushar.27r@gmail.com 
Dr Nikhil Prasun   Medique Clinic and Diagnostic 274  Department of neurology, G T Road Liluah Belur, Howrah, West Bengal -711204
Haora
WEST BENGAL 		 93314 83809

nikhil.prasun@gmail.com 
Dr Sushma Sharma  Metro Heart Institute with Multispecialty  Department of neurology, Nirman Kunj ADB PWD Colony Sector 16A Faridabad Haryana 121002
Faridabad
HARYANA 		 9896649276

drsushma123@gmail.com 
Dr Asad Abbas  Neuro Care Centre Clinic,  Department of neurology, 605-B Felix Sqaure near lulu mall, Sushant golf city Lucknow-226030
Lucknow
UTTAR PRADESH 		 9415073512

asad.abbas@rediffmail.com 
Dr Rajesh B Iyer  Poorna Neuro. Super Speciality Clinics  Department of neurology, 89/1 2nd Floor Nagasri Arcade Service Rd Chellikere Kalyan Nagar
Bangalore
KARNATAKA 		 9880562917

rajeshbiyer@gmail.com 
Dr Soaham Desai  Shree Krishna Hospital and Research Center,  Department of Neurology Anand - Sojitra Rd, Gokul Nagar, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT 		 9979937885

drsoahamdesai@yahoo.com 
Dr Lakshmi Narasimhan  SRMC Hospital  Department of neurology ,Ramachandra Nagar, porur, Chennai-16
Chennai
TAMIL NADU 		 9444380409

lakshmineuro@gmail.com 
Dr UK Misra  T.S. Misra Medical College & Hospital  Department of neurology, opp. Railway Station, Amausi, Anora, Lucknow, Uttar Pradesh 226009
Lucknow
UTTAR PRADESH 		 9450653685

drukmisra@rediffmail.com 
Dr Rahul Chakor  Topiwala National Medical College & BYL Nair Charitable Hospital  Department of neurology,Dr.A.L. Nair Road,400008
Mumbai
MAHARASHTRA 		 223027630

drchakorrt@yahoo.com 
Dr Neeraj Jain   VARDHAMAN NEUROCARE  Department of Neurology, VARDHMAN MARKET, 301, PLOT NO, opposite Union Bank opposite LIC office Sector 17 Vashi
Mumbai
MAHARASHTRA 		 9930715878

neeraj2you@gmail.com 
Dr Balapradeep Boyidapu  Visakha Institute of Medical Sciences  Department of Neurology,Visakha Institute of Medical Sciences 18-23/1, Mudasarlova Rd, Pedda Gadhili, Hanumanthavaka, Visakhapatnam Andhra Pradesh-530040
Visakhapatnam
ANDHRA PRADESH 		 7021287683

drbbalapradeepresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Institutional Ethics Committee of Topiwala National Medical College and BYL Nair Charitable Hospital  Approved 
Institutional Fortis Memorial Research Institute  Approved 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
Good society ethical research   Approved 
Indira IVF hospital ethics committee  Approved 
Indira IVF hospital ethics committee  Approved 
Indira IVF hospital ethics committee  Approved 
Indira IVF hospital ethics committee  Approved 
Institutional Ethics Committee - IEC TSMMCH  Approved 
INSTITUTIONAL ETHICS COMMITTEE BHAIKAKA UNIVERSITY KARAMSAD  Approved 
Institutional Ethics Committee Visakha institute of medical sciences,Vishakhapatnam  Approved 
Kauvery Institutional Ethics Committee  Approved 
KIMS Foundation & Research  Approved 
KIMS KINGSWAY HOSPITALS ETHICS COMMITTEE  Approved 
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Metro super specialty ethics committee  Approved 
Rudraksha Hospital Ethics Committee  Approved 
S2J Independent Ethics Committee  Approved 
Sri Ramachandra University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G437||Chronic migraine without aura, (2) ICD-10 Condition: G431||Migraine with aura, (3) ICD-10 Condition: G430||Migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Nerivio  The Nerivioâ„¢ device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Nerivio is intended for the acute and preventive treatment of migraine with or without aura in patients 12 years of age or older. It is self applied to the upper arm. Treatments are self-administered by the user at the onset of a migraine attack. The device delivers extra-cephalic transcutaneous electrical stimulation below the pain threshold to the skin of the upper arm at the onset of a migraine attack.The device is comprised of 3 main components: 1) Armband with attached electrodes, 2) Electronics case and 3) Software including Firmware and Mobile Application software to be run on a mobile platform. Nerivio should be used within 60 minutes of migraine symptom onset for 45 minutes, with a device usage duration of 1 month or 4 qualified treatments, whichever occurs first. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age 12-75 years old
2. Meeting the ICHD-3 diagnostic criteria for migraine with or without aura.
3. Participants must be on a stable dose of a single migraine preventive medication during the 2 months before enrollment.
4. Must be able and willing to comply with the protocol.
5. Must be able and willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  1. Use of antipsychotics on a regular basis during the 3 months prior to consideration for enrolment.
2. Having implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nervestimulator).
3. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
4. Known uncontrolled epilepsy.
5. Any use of Cannabis, including medical use.
6. Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
7. Change in oral migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.
8. Subject is participating in any other clinical study.
9. Not having the basic cognitive and motor skills needed tooperate a smartphone.
10. Pregnant, or trying to get pregnant or breastfeeding female participants. Details regarding UPT (Urine Pregnancy Test) results must be documented.
11. Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
12. Subject is experiencing a menstrually-related migraine.
13. Received OnabotulinumtoxinA/any botulinum toxin injections, parenteral infusions for migraine within the previous 3 month.
14. Subject participated in a previous study with the Nerivio device.
15. Subject with arm circumference below 7.9 inches (20 cm).
Note - Females of childbearing potential must have a negative pregnancy test and must be willing to use adequate contraception during the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction of migraine pain at 2 hours:
Proportion (%) of subjects reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their second treated migraine attack (excluding the first treatment). 		 2 hours post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Freedom from most bothersome migraine-associated symptom (MBS) at 2 hours:
Proportion (%) of subjects reporting, 2 hours post-treatment, freedom from their MBS other than a headache, in their second treated migraine attack. MBS may be nausea, or vomiting or photophobia, or phonophobia or combination of them −as defined by each subject at the beginning of the treatment. 		 2 hours post treatment  
Pain and MBS relief at 2 hours:
Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 2 hours post- treatment. 		 2 hours post treatment 
Pain-free at 2 hours:
Proportion (%) of subjects reporting freedom from migraine pain at 2 hours post-treatment without rescue medications in their second
treated migraine attack. Pain-free is defined as improvement from mild, moderate, or severe pain to none. 		 2 hours post-treatment  
Rescue medications use within 2 hours:
Proportion (%) of subjects reporting use of rescue/acute medication within 2 hours post-treatment in their second treated migraine attack. 		 2 hours post-treatment  
Sustained MBS freedom at 24 hours:
Proportion (%) of subjects reporting post-treatment response to the first secondary endpoints at 24 hours. 		 24 hours post treatment  
Sustained pain and MBS Relief at 24 hours:
Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 24 hours. 		 24 hours post treatment  
Sustained pain-free at 24 hours with a single use of the device: Proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 24 hours, in their second treated migraine attack.  2-24 hours post treatment  
Rescue medications use between 2-24 hours:
Proportion (%) of subjects reporting use of rescue/acute medication between 2- and 24-hours post-treatment in their second treated migraine attack. 		 2-24 hours post treatment  
Within-subject consistency of the primary endpoint in subsequent treatments:
The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequently treated attacks.
Thus, this endpoint measures the % of subjects responding to the
primary endpoint in at least 50% of their treated attacks.
 		 2-24 hours post treatment 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) 25/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary  

Nerivioâ„¢, a neurostimulation device, is intended for the acute and prophylactic treatment of migraine with or without aura in patients 12 years or older.

The device delivers transcutaneous electrical stimulation below the pain threshold to the patient’s upper arm. The level of generated stimuli is similar to other FDA-approved electro-stimulation devices. The treatment is self-administered and controlled by a dedicated smartphone application. It is believed to alleviate pain through conditioned pain modulation.

This is a prospective, single arm, multicentric, open label trial in which At least 200 subjects will be enrolled as per the inclusion criteria, and Objectives of this study is to demonstrate the safety and effectiveness of Nerivioâ„¢ device for the acute treatment of episodic and chronic Migraine.

This study will be conducted in two stages: 

Stage One – Enrollment and Training:

The first visit will include screening, enrollment and training on the device. The enrollment and device training may occur in two separate visits instead of one.

Subjects with a history of episodic or chronic migraine (as per inclusion criteria) (1) with or without aura, with no complication (i.e., Status migrainosus, Persistent aura without infarction, Migrainous infarction, Migraine aura-triggered seizure), who met the International Classification of Headache Disorders (ICHD-3 Section 1, Diagnostic Criteria for Migraine) (2) will be included.


First visit:

The first visit will include screening, enrollment and training on the application. Eligible participants will be trained to use the Nerivioâ„¢ device, associated smartphone app and migraine diary. Subjects will be asked to complete the diary at the enrollment visit by recalling events of

their migraine attacks for the last one month. They will be trained to capture data on the trial diary. (3) Device instructions for use will be available in a separate document which will be provided to the participants with the Nerivioâ„¢ device.


Stage Two - Single-arm, open-label treatment stage:

Following successful completion of training, subjects will be asked to apply the device and administer treatment for every migraine attack they experience. At the onset of their migraine attack, subjects will report the results of every treatment using the migraine diary.

Final visit: End of study:

Participants will return the device to the clinic following the end of the study.

Duration for each subject will be approximately one- month of treatment or up to four qualified migraine attacks (whichever is achieved first).
 
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