Design of Migraine Management Device

Project Title

Design of Migraine Management Device

Project Area of Specialization Biomedical EngineeringProject Summary

Neurological disorders are affecting the global population in a negative way about which the United Nations General Assembly had stressed that the work being done to reduce it is insufficient to meet the United Nations Sustainable Development Goals (SDGs) targets by 2030 [1]. Migraine is also one of those disabling neurological diseases and globally stands 2nd among the most disabling diseases and as per the World Health Organization (WHO), globally 1/2 of the adult population is affected by different types of headache of which 1/3rd are migraine sufferers which constitutes 1 Billion and 12% of the Global adult population [2][3].

Migraine is considered to be triggered by stress, aura, smell, taste, bright light, noise and changes in sleep timings. This results in mild to severe headache in sides of the head which can further escalate into nausea, visual disturbance, dizziness and some related symptoms. The headache may last from few hours to several hours and even days resulting in a sudden disability to the patient that may cause hindrance in daily routine tasks [4].

Some migraineurs may opt for long-term preventive treatments that usually require consuming a complete course of medications and some migraineurs even use usual pain killer tablets that have been reported to result in comorbidities related to heart and hormone functions and yet these methods are not so effective in dealing with the disease completely [5]. Use of neuromodulation devices is also observed which employs the use of electrical or magnetic signals for stimulating the nerves in order to modulate the neural activity [6][7]. These neuromodulation devices are in clinical practice in some developed countries but these devices on an average cost more than $400 and are not available locally, so if it is to be imported then the cost would raise even more. Also, these devices have been reported to have its own side-effects as the output stimulation parameters are high and causes itching, tightness on head, tingling and burning sensation which creates another burden for migraineur.

All of these factors pertaining to migraine results in annual loss of about $17 billion and not just economically but socially this disease has been observed to increase anxiety and stress on the migraineur and the people around them [8]. So, a non-invasive neuro-stimulation device is to be developed that modulates the neural activity during migraine attack as it delivers a controlled low-intensity current across the scalp and a head massage which helps in relieving the condition of a migraineur during migraine attack without having any potential adverse effect in order to replace side-effective pharmacological solutions and expensive clinical therapeutics.

Project Objectives

To design a wearable neuro-stimulation device that delivers a controlled low intensity current across the scalp via conductive sponge electrodes placed at the locations of trigeminal and occipital nerves and a ganglion massager that delivers mechanical vibrations at the location of temples on head to manage migraine.

Project Implementation Method

The project implementation method is designed to be carried out in a systematic manner with first and the foremost task is to get to know about the severity of migraine and its impact across the globe and locally. For this purpose, the World Health Organization and Migraine Research Foundation’s statistics are to be referred for global data and as local data is unavailable, so a survey is imperative to be conducted initially under the project to determine the prevalence of migraine and the ways in which migraineurs copes with it. After this a thorough process of literature review is to be conducted and the disease to be studied from various aspects starting from its global burden, right to the options available for migraine. The idea that is devised and design for neuro-stimulation device is prepared after which relevant components and equipment are to be procured for initial design. The initial circuit is to be developed using simulations and then practically implemented to confirm its validity. The circuit can then be implemented on vero board by soldering and initial prototype will be prepared for bench test, in which different resistances can be used as load impedance to validate the required output.

In the next stage the design and incorporation of ganglion massager is to be implemented after which the final circuit is to be implemented as a soldered circuit to validate the output and then be implemented as printed circuit board. After which the device will undergo human testing on subjects first under clinical setting and this process is subjected to approval from the Ethical Review Committee of the University. The designed device will then be converted into a product to be patented.

Benefits of the Project

The project would offer the following benefits upon its completion.

• Non-invasive and non-pharmacological solution to Migraine.
• Point-of-Care solution for Migraine management.
• Portable device as it can be carried along.
• Migraineur can wear it as a cap, upon migraine attack.
• Adjustable according to each user’s head due to its flexible strap.
• Pocket friendly & Pocket Carriable.
• One-time purchase with no side-effects.

Technical Details of Final Deliverable

The final deliverable of this project will be a cost effective, battery operated, non-invasive and non-pharmacological therapeutic intervention that will produce favorable effects in medical realm by managing the pain and reducing the sufferings of migraineurs during migraine attack. The proposed intervention will deliver low intensity direct electrical current of 2mA to stimulate/excite definite brain regions involved/associated with migraine. In-order to ensure aesthetics, final deliverable of the proposed project will also include a design headset comprising of a mechanical massager to improve the efficiency of the neuro-stimulator and provide relief to migraine patients. The final device protype will be wearable like a cap and can be carried along by the patient. The design would be compact but stretchable and can be easily adjusted on patient's head.

Final Deliverable of the Project Hardware SystemCore Industry HealthOther Industries Medical Core Technology NeuroTechOther Technologies Wearables and ImplantablesSustainable Development Goals Good Health and Well-Being for People, Partnerships to achieve the GoalRequired Resources

Item Name	Type	No. of Units	Per Unit Cost (in Rs)	Total (in Rs)
			Total in (Rs)	79945
Breadboard	Equipment	3	160	480
Veroboard	Equipment	6	50	300
Soldering Wire	Equipment	3	100	300
Soldering Iron	Equipment	1	900	900
3.7V Li-ion Batteries	Equipment	5	100	500
9V Battery	Equipment	3	100	300
Arduino NANO	Equipment	1	750	750
Raspberry pi	Equipment	1	11250	11250
Mechanical Actuators	Equipment	3	5000	15000
Fiber PCB Board and PCB printing	Equipment	3	2600	7800
Wires & Connectors Pack	Equipment	5	400	2000
Digital potentiometer packs	Equipment	2	2500	5000
Electrodes packs	Equipment	3	2000	6000
Resistor Sheet	Equipment	3	120	360
Capacitor Pack	Equipment	3	200	600
Transistor Pack	Equipment	2	150	300
LM334 IC	Equipment	10	200	2000
LM324 IC	Equipment	5	25	125
LM317 IC	Equipment	3	20	60
TL431 IC	Equipment	3	20	60
LM741 IC	Equipment	1	20	20
DC Booster	Equipment	1	150	150
3D Printing of Headset	Equipment	1	15000	15000
Switch & Battery Connector	Equipment	2	40	80
ACS712 IC	Equipment	2	250	500
IRF4905 MOSFET	Equipment	1	110	110
Report Printing Mid	Miscellaneous	1	1200	1200
Report Printing Final	Miscellaneous	1	2500	2500
Fuel use for project work	Miscellaneous	4	1500	6000
Photocopies & Binding	Miscellaneous	3	100	300