WO2016135475A1

WO2016135475A1 - Apparatus for altering the mood of an individual

Info

Publication number: WO2016135475A1
Application number: PCT/GB2016/050458
Authority: WO
Inventors: Frederick BOY
Original assignee: Swansea University
Current assignee: Swansea University
Priority date: 2015-02-23
Filing date: 2016-02-23
Publication date: 2016-09-01
Anticipated expiration: 2017-08-23
Also published as: GB201503004D0

Abstract

An apparatus, in the form of a headset (20), to deliver stimulation to the brain of an individual which has a support member (22) with two ends each having an earpiece (24). The support member is configured to pass from the first earpiece over the skull of the individual to the second earpiece, wherein the support member also has at least one locator to which at least one electrode can be secured so that at least one electrode (30) when attached to the support member is located forward of the support member so as to be in proximity to the front lobes of the skull so that electrical stimulation can be delivered to the individual's brain at precise locations.

Description

Apparatus for Altering the Mood of an Individual

Field of the Invention

The invention relates to an apparatus for altering the mood of an individual. In particular but not exclusively the apparatus is arranged to improve the mood of a mammal by modulating the electrical activity of the individual's central nervous system and underlying biochemistry.

Background of the Invention

According to recent statistics, 77% (179 million) of adults in the US regularly experience physical symptoms caused by emotional stress and 73% (169 million) regularly experience psychological symptoms. Almost 50% of Americans feel stress has increased over the past 5 years. Most common causes of emotional stress include job pressures, financial hardships, ill-health concerns, relationships, poor nutrition and media overload. It is when emotional stress reaches intense levels for long periods of time that physical and/or mental health issues may arise which drives people to seek medical help. Help is typically in the form of prescribed antidepressants and anti-anxiety medications. Medication is undoubtedly effective to improve mood states and reduce anxiety, however these drugs are addictive and can cause many adverse side effects, which, in turn counteract the positive effects of the drugs (e.g., appetite and weight-loss, sleep and sexual malfunctions are very common). Other forms of treatment involve psychotherapy or counselling which can be costly and can take time to be effective if at all, for example several months to several years, and if the individual is paying for such treatment this can be quite a financial burden. Also an estimated 25% of patients with low mood do not respond or fully respond to the conventional solutions provided by the medical or counselling services those individuals may turn to self-medication or even worse they are more likely to develop addiction to alcohol and illegal drugs.

Devices have been used to stimulate the nerves in the cranium for the treatment of mental disorders, for example in US 200413870, and these typically involve placing pads on the skull and an electrical impulse is administered at varying frequencies. The pads and location of the stimulation needs to be carefully controlled and this involves a medical practitioner placing the pads in the correct position. Furthermore because a medical practitioner is involved this means that the individual is in a hospital environment and so has often reached a crisis point where their treatment is needed.

To date, there are unfortunately no devices that an individual can use to treat themselves to alter their mood without involving a medical practitioner and which is free of adverse- effects and at the same time, remains cost-effective.

The present invention seeks to overcome problems with the prior art by providing an easy to use device that when applied to the head by a user, without the need for medical assistance and which allows for the application of electrical current stimulation. Such applied electric current stimulation of the brain, also known as trans cranial direct current Stimulation, (tDCS) appears to significantly improve dispositional mood and help and individual to recover a sense of well-being.

Summary of the Invention

According to the present invention there is provided an apparatus for delivering energy stimulation to the brain of an individual, said apparatus comprising a support member having a first end and a second end, said first end having a first earpiece and the second end having a second earpiece, said first and second earpieces being configured to be located on or in proximity to respective ears of the individual, with said support member being configured to be positioned to pass from the first earpiece over a position on the skull of the individual to the second earpiece, wherein the support member also has at least one locator to which at least one energy delivery member can be secured so that the at least one energy delivery member when attached to the support member is located so as to be in proximity to the front lobes of the skull so that energy stimulation can be delivered to the individual's brain.

Typically the apparatus is a headset for delivering electrical stimulation to the brain. The support member is arranged to pass from the first earpiece over the top of the skull of the individual to the second earpiece, wherein the support member also has at least one locator to which at least one electrode can be secured so that the at least one electrode when attached to the support member is located forward of the support member so as to be in proximity to the front lobes of the skull so that electrical stimulation can be delivered to the individual's brain. The stimulation is an external stimulation which typically is selected from one or more of direct electric current, alternating electric current, ultrasound, visible or invisible light radiation.

Preferably the support member is provided as a head-band.

Preferably said head-band includes at least one expandable region permitting a distance between the first end and the second end to be selectably varied to alter the distance between the first and second earpieces.

It is envisaged that the expandable region is formed of a flexible material.

It is preferred that the flexible material is selected from one or more layers of flexible materials including at least one of medical foam, polyamide, polyester, and aramid.

It is preferred that the support member includes circuitry to deliver stimulation such as electrical stimulation to the brain of the individual.

Preferably the circuitry is enclosed within the support member.

It is preferred that the apparatus includes at least two securing devices coupled to the support member, wherein the at least two securing devices are configured to fit behind ears of a subject and support the first and second earpieces in proximity to the ears.

Alternatively the earpieces are provided as ear pads to fit over the ears.

It is envisaged that the earpieces are arranged to transmit sound to the individual. The sound can be soothing music or sounds such as the sound of running water that can help relax the individual. It is preferred that the head-set has connectors for at least two electrodes, a first electrode to be positioned over the front left lobe of the individual's brain and the second to be positioned over the front right lobe of the individual's brain.

Preferably the energy delivery members such as electrodes are connected to the headset by connecting members that hold the electrodes in a position forward of the headset and in proximity to the frontal lobes of the brain of an individual.

It is preferred that the first and second energy delivery members e.g. electrodes are positioned over the F3 and F4 locations of the skull.

Preferably the first and second energy delivery members are releasably attached to the headset.

It is envisaged that the first and second energy delivery members include a stimulus emitter formed of a piezoelectric transducer.

It is preferred that the apparatus, e.g. a headset is configured to communicate via one or more communication lines with a base unit, the base unit including software and hardware configured to analyse brain electrical activity data received a sensor on the individual. The sensor may act as a feedback to monitor how the mood enhancement is proceeding in response stimulation e.g. to electrical stimulation using the electrodes.

Preferably the apparatus is configured to communicate wirelessly with a base unit.

It is envisaged that the apparatus includes an integrated display located on the support.

It is preferred that the integrated display includes an LED or an LCD display.

It is preferred that one or more components are disposable and in particular the one or more electrodes are disposable.

Preferably the electrodes comprise a connector to enable the one or more electrodes to be attached to the connecting members or directly to the headset, a support body and a layer of conducting material, to enable transmission of an electrical stimulus to a surface on which the one or more electrodes are placed

It is envisaged that the electrode is provided in a blister pack with the layer of conducting material being overlaid with a porous material that is separated from a solution by a separation layer such that when the separation layer is removed the porous material absorbs the solution.

Brief Description of the Figures

An embodiment of the present invention will now be described by way of example only, with reference to and as illustrated in the accompanying figures in which:

Figure la) shows a side view of various regions of the brain;

Figure lb) shows the coordinates used as representations of the areas of the brain;

Figure 2 shows a device representation of the attachment of a linker molecule to the surface of a first particle with two sizes of particles being shown;

Figure 3 shows: an electrode to be used with the headset according to a first embodiment of the invention; and

Figure 4 shows: an alternative form of electrode to be used with a headset according to the invention

Detailed Description of Embodiments of the Invention

The brain is divided into various regions as shown in Figure la. The nasion 1 where the frontal bone and the two nasal bones intersect is found at the front of the skull between the eyes. The frontal lobes 2 are found towards the front of the skull and these are separated from the parental lobes of the brain, which can be found towards the rear of the skull by the Rolandic Fissure 3. The Rolandic Fissure is found generally in the region of the top of the skull, just forward of the crown of the head. Running up the side of the brain from an area in front of the ears is the Sylvian Fissure 5, which separates the front and parental lobes superiorly from the temporal lobe 8. The Occipital lobe 6 is towards the rear of the brain and this is in proximity to the inion 7 of the skull which is the prominent projection at the lower rear part of the skull. If a line is drawn from the nasion 1 to the inion 7, this bisects the brain into left and right portions of brain. The Sylvian and Rolandic fissures generally bisect the brain from front to back as shown in Figure lb.

In Figure lb we see some of the locations as defined by the International 10/20 and Extended 10/10 Systems, of scalp electrodes F3, F4, Fz, and Pz. The Fz position can be found on a line generally passing from the nasion to the crown of the head where the Cz position is located. The Rolandic fissure extends across the head and slightly behind the Cz position. The Pz location is generally midway on a line drawn from the Cz position to the inion. As can be seen, the line between the nasion and the crown and between the ears (which generally follows the Rolandic fissure form a boundary that defines the area of the skull above left and front lobes of the brain respectively. The position F3 is located generally in the centre of the left area while the position E4 is located generally in the centre of the right area of the brain. The areas of the brain affecting mood are the frontal lobes but precise location of electrodes is needed for the correct stimulation of the brain in order to alter mood. Misplacement of the electrodes can result in either no alteration of the mood or at worse incorrect stimulation of the brain which could have an adverse effect on the individual's mood.

Although it is important that the F3 and F4 sites are stimulated, electrodes could be placed at other scalp positions or at a fewer or greater number of sites, depending on the specific requirement of the medical or research application but the electrodes must be positioned over F3 and F4 to have an effect on the mood of an individual.

The headset apparatus may comprise means for delivering an electrical stimulus to the individual and such stimuli include tDCS (transcranial direct current random noise stimulation) or RNS (random noise stimulation) or tACS (transcranial Alternative Current Stimulation).

Typically, tDCS involves the application of a low frequency oscillatory current, or a weak direct current, to modulate the functioning of targeted groups of neurones in the subject's brain. The direct current delivered by the apparatus may therefore be between 100 pA and 3000 pA. In the case of alternative current, the current may be oscillated between 100 pA and 3000 pA, and between 0.1 Hz and 1000 Hz. Different current intensities and frequencies may apply to different electrodes at different times. The apparatus may be adapted to deliver the electric energy to the brain for any duration between 30s and one hour per session.

The delivery of the electrical stimulation is by means of apparatus as shown in Figure 2. The apparatus is in the form of a headset 20 similar in general form to a set of audio headphones. The headset has a main elongate body 22 that is curved in such a fashion as to fit over a person's head when in use. Attached at either end of the elongate body 22 are first and second earpieces 24 arranged to extend inwardly towards each other from the ends of the elongate body 22. Each earpiece 24 is shaped so as to either fit over the user's ear or fit in the user's ear. In preferred arrangements adjustable mountings 26 are provided to attach the earpieces to the main body 22 that permit some adjustment of the orientation of the earpieces relative to the ends of the main body. For example, each earpiece 24 and end section of the main body 22 may be formed with cooperating ball & socket attachments that permit a degree of movement of the earpiece relative to the main body.

An electrode carrier 28 extends substantially orthogonally from the main body 22 of the headset to which a number of electrodes 30 are attached. In the example illustrated in Figure 2 two electrodes are shown, however the number of electrodes may vary. The primary function of the electrode carrier 28 is to locate the attached electrodes 30 at a specific distance and orientation from the main body 22 of the headset, as will be described further below, such that when the headset is worn by a user the electrodes 30 are located forwards of the main body 22 with respect to the user's head. Consequentially, although the electrode carrier 28 is illustrated in the example shown in Figure 2 in the form of a curved bar extending from separate locations on the main body 22, other arrangements may be adopted. For example, the electrode carrier 28 may be in the form of a t-shaped bar with a central leg of the T extending from a central location of the main body 22 and the electrodes 30 attached along a cross section of the T. A power control unit 32 is also attached to the main body 22 of the headset. The power control unit is electrically connected to each of the electrodes 30, for example by means of one or more conductive wires. In preferred embodiments the electrical connections between the power control unit 32 and the electrodes 30 are located within the main body 22 of the headset and the electrode carrier 28 so as to prevent damage occurring to them when the headset is in use. However, external wiring may be used in other embodiments. Preferably, the power control unit 32 includes an electrical power source, typically a battery, and a power regulator arranged to control the delivery of electrical energy from the power source to the electrodes as desired. In this arrangement the apparatus allows freedom of movement of the user's head when the headset in is use. However, in other embodiments the power source may be located separately from the headset, in which instance the power control unit will include a connector arranged to be connected to the remotely located power source utilising a power lead, for example. Equally, it may be desired for neither the power source or power regulator to be integrated with the headset, in which case the power control unit 32 will simply include a suitable electrical interface unit arranged to receive electrical signals from an external source and transmit those signals to the desired electrodes 30.

Figure 3a illustrates the structure of an electrode according to an embodiment of the present invention in more detail. Each electrode has a base substrate 40 formed from an electrically insulating material. Attached to the substrate 40 is an electrically conductive layer 42, which in turn is covered with a conductive coating 44. The conductive coating 44 preferably has a relatively high viscosity or has some adhesive properties such that when the electrode is placed on the user's scalp the coating 44 functions to resist unintended movement of the electrode relative to the scalp. Each electrode 30 also includes a mounting element 46 that is arranged to releasably secure the electrode to the electrode carrier 28 of the headset. The mounting element 46 may be in the form of a clip or screw bracket, or other suitable releasable mounting means. Each electrode is also preferably provided with sealed cover 48 (shown in Figure 3b) covering at least the conductive coating 44 and arranged to be removed before the electrode is used. The function of the coating is to maintain the conductive coating in usable state, e.g. to prevent drying out or reduction in adhesiveness. Figure 4 shows an alternative form of an electrode to that shown in Figures 3a and 3b. The electrode in Figure 4A has a porous medium 49, such as a sponge material that comes into contact with the scalp rather than a coating of electrically conductive material as shown in the previous embodiment. As for Figures 3a and 3b, the electrode has a mounting system 46 to allow for attachment to a support on a headset. There is an insulated support frame 40 which in turn is covered by a conductive material which is covered by a sponge. The sponge in Figure A is dry. However it is possible to have a sponge similar to that in Figure 4 which can be hydrated as in Figure 4B. The sponge is covered by a separator film 50 which separates the sponge from a solution that is in a in a solution 5 la that is held in a container 52 that forms a blister pack for the electrode. The solution is typically 0.90% weight by volume of sodium chloride. The saline is contained in a blister pack 52. As shown in Figure 4C the separator film 50 can be removed or punctured and this allows solution to flow into the sponge 49 which leaves a void 5 lb in the container 52. The wetted porous medium can then be placed on the scalp of the individual. Typically the porous medium may have a gel like consistency so that there is better contact with the scalp of an individual.

As the apparatus is in the form of a headgear, with the at least one electrode, the electrical energy storage device (if present) and the electronic circuitry or chip regulating the delivery of the electrical energy to brain being integral with the device this allows for a self contained piece of apparatus that allows freedom of movement. This is because there are no wires etc which restrict the movement of a wearer as is the case in known devices.

The apparatus can be used to improve mood states and reduce the negative psychological consequences of exposure to stressful situations. The invention also extends to methods for improving cognitive performance. This combined with an adjustable system allowing to properly position electrodes in position regardless of head sizes encountered in the human population. This adjustable positioning mechanism will permit to accommodate for different head size, and therefore to stimulate similar brain regions in different human subjects by individuals without the need for assistance from a medical practitioner. This is because the apparatus uses fixed location points such as the ears and a headset which has predetermined locators for the attachment of stimulators, such as electrodes in the desired F3 and F4 positions. The invention has applications not only in mood enhancement but also in pain relief, rehabilitation after a stroke, relief from severe headaches and cognitive enhancement.

It is to be understood that the above embodiments have been provided only by way of exemplification of this invention, such as those detailed below, and that further modifications and improvements thereto, as would be apparent to persons skilled in the relevant art, are deemed to fall within the broad scope and ambit of the present invention described. Furthermore where individual embodiments are discussed, the invention is intended to cover combinations of those embodiments as well. The systems shown and described are not limited to the precise details and conditions disclosed. Method steps provided may not be limited to the order in which they are listed but may be ordered any way as to carry out the inventive process without departing from the scope of the invention. Furthermore, other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangements of the exemplary embodiments without departing from the scope of the invention as expressed in the appended claims.

Claims

1. An apparatus for delivering energy stimulation to the brain of an individual, said apparatus comprising a support member having a first end and a second end, said first end having a first earpiece and the second end having a second earpiece, said first and second earpieces being configured to be located on or in proximity to respective ears of the individual, with said support member being configured to be positioned to pass from the first earpiece over a position on the skull of the individual to the second earpiece, wherein the support member also has at least one locator to which at least one energy delivery member can be secured so that the at least one energy delivery member when attached to the support member is located so as to be in proximity to the front lobes of the skull so that energy stimulation can be delivered to the individual's brain.

2. An apparatus according to claim 1, wherein the support member is provided as a headband.

3. An apparatus according to claim 1 or claim 2, wherein the head-band includes at least one expandable region permitting a distance between the first end and the second end to be selectably varied to alter the distance between the first and second earpieces.

4. An apparatus according to claim 3, wherein the expandable region is formed of a flexible material.

5. An apparatus according to claim 4, wherein the flexible material is selected from one or more layers of flexible materials including at least one of medical foam, polyamide, polyester, and aramid.

6. An apparatus according to any preceding claim wherein the support member includes circuitry to deliver external energy stimulation to the brain of the individual.

7. An apparatus according to claim 6, wherein said external energy is selected from one or more of direct electric current, alternating electric current, ultrasound, visible or invisible light radiation.

8. An apparatus according to claim 6 or claim 7, wherein the circuitry is enclosed within the support member.

9. An apparatus according to any preceding claim having at least two securing devices coupled to the support member, wherein the at least two securing devices are configured to fit behind ears of a subject and support the first and second earpieces in proximity to the ears.

10. An apparatus according to any of claims 1 to 8, wherein the earpieces are provided as ear pads to fit over the ears.

11. An apparatus according to any preceding claim wherein the earpieces are arranged to transmit sound to the individual

12. An apparatus according to any preceding claim having one or more connectors for at least two energy delivery point, a first energy delivery point to be positioned over the front left lobe of the individual's brain and the second to be positioned over the front right lobe of the individual's brain.

13. An apparatus according to any preceding claim wherein the connectors hold the energy delivery point in a position relative to the apparatus and in proximity to the frontal lobes of the brain of an individual

14. An apparatus according to any preceding claim wherein the first and second energy delivery members are positioned over the F3 and F4 locations of the brain.

15. An apparatus according to any preceding claim wherein the first and second energy delivery members are releasably attached to the headset.

16. An apparatus according to any preceding claim wherein the first and second energy delivery members include a stimulus emitter and in particular a piezoelectric transducer.

17. An apparatus according to any proceeding claim wherein the apparatus is configured to communicate via one or more communication lines with a base unit, the base unit including software and hardware configured to analyse brain electrical activity data received from the at least one sensor.

18. An apparatus according to claim 17 configured to communicate wirelessly with a base unit.

19. An apparatus according to any preceding claim that includes an integrated display located on the support.

20. An apparatus according to claim 19, wherein the integrated display includes an LED or an LCD display.

21. An apparatus according to any preceding claim wherein one or more components are disposable and in particular the one or more energy delivery points are disposable.

22. An apparatus according to any preceding claim wherein the one or more energy delivery members comprise a connector to enable the one or more energy delivery members to be attached to a connecting members on the apparatus or directly to the apparatus, a support body and a layer of conducting material, to enable transmission of an energetic stimulus to a surface on which the one or more energy delivery members are placed.

23. An apparatus according to claim 22, wherein the energy delivery members deliver electrical energy

24. An apparatus according to any preceding claim including means to adjust and control the delivery of energy to the scalp via the electrodes,

25. An apparatus according to claim 24 including a timer with a time maximum to limit the amount and length of time that energy is delivered.

26. An apparatus substantially as described herein with reference to and as illustrated in the accompanying figures.