Novel brainwaves modulator from Alfa rhythm LTD

headband

Alfa rhythm LTD devices aim to help people to master their brain waves according to their need and will.
Alfa Rhythm Device & Technology

The device transmits low voltage (3.6V) electronic pulses with specific frequencies addressing different indications:
Wellness: Calm, Sleep, stress, Headache, focus and alertness
The company has 5 types of devices (2, 3, 9,13 Hz) for 5 different wellness uses. Treatment time is 30 minutes.
Alfa Rhythm devices are CE marked for wellness. and could be sold for this purpose in USA without special  FDA approval.
The current devices are an electronic apparatus designed to emit a range of electric pulses, characterized by a user-established frequency, stimulating the brain to imitate the current frequency at work. When compared to standard known trans-cranial magnetic stimulation devices, substantial advantages merit it being a multi-purpose self-operated revolutionary approach for mental stimulation. Alongside psychological and wellness oriented issues such as depression, sleepless and lack of concentration , results of tests conducted to date display increased mental function and creativity provides the user with alertness, a sense of tranquility and mental sharpness, aimed at enhancing complex problem solving abilities characterizing dynamic environments. Research-based results involving EEG measurements support optimal cerebral stimulation though use of Delta, theta, alpha and beta wave frequencies, comprising a range of 2-23 Hz, activated with very soft and safe voltage(3.6 volt battery) enabling the brain to sustain level of prowess up to hours after actual stimulation has ceased.
Ease of autonomous-use, compact devices involving immediate attaching to forehead, and non-hazardous prolonged continuous stimulation.

Focus and Attention (TCD 9)

The device helps you balance your brain waves and leaves you in a High alpha state: stimulated, and concentrated; in both aspects: physical and mental functionality.
This device gives you an optimal effect, when you decide and desire to be in that state, while sharpening your senses and enhancing your functionality. This device sends rapid low frequencies  that activate and balance the brain to help in balancing hyperactivity and strengthening focus and concentration.
General wellbeing and learning disability (TCD 13)

The device helps you balance your brain waves and leaves you in a low beta state: stimulated, and concentrated; in both aspects: physical and mental functionality.
This device gives you an optimal effect, when you decide and desire to be in that state. This device sends rapid low frequencies  that activate and balance the brain to help in relieving learning diability symptoms and also in stimulating body and mental functionality.

Reduction of Stress and Symptoms of Migraine and Headache(TCD 2)

The device helps you balance your brain waves and leaves you in a Delta state: calm, and relaxed; in both aspects: physical and mental functionality.
This device gives you an optimal effect, when you decide and desire to be in that state. This device sends rapid low frequencies  that activate and balance the brain to help in relieving pain and headache symptoms and also in relaxing body.

Device For Insomnia(TCD 3)
Feel relaxed and fall asleep.

The device helps you balance your brain waves and leaves you in a Delta state: calm, and relaxed; in both aspects: physical and mental functionality.
This device gives you an optimal effect, when you decide and desire to be in that state, This device sends rapid low frequencies  that activate and balance the brain to help in relieving sleepless and also in relaxing body.


New generation Modulator   wristband01

Transmission of electric pulse frequency from wrist to brain 

The smart wristband transmits electric pulse to the body with 1-43 Hz , with option that the user chose the hertz he selects ,
The watch includes frequency generator in addition to the following specifications:

1. Battery: Lithium Ion polymer battery
 Capacity:  3.7V/80mAH
  Standby Time: 7-10days
Color: Black,Blue, Red
 Dimension: 250*24*13mm
2.Heart rate detection
3. Waterproof IP67 depth
4. Green light static heart rate monitoring(Stress Meter)
5.Language:English,
6.charger type:USB connector
7. two electrodes
 8. Timer: It is managed to work 30 minutes automatically with option to stop it manually
9. Code tech: It is managed to program 4 treatments, with option of change.

The Wristband Monitor is still not connected with SDK and will be managed at the next year to be connected SDK and Bluetooth with a special program for collecting data arriving to personalization, and will be suitable for Android and IOS 
The company is managing now production of 1000 devices without SDK and Bluetooth.

Concerning electric plus to body” that means an electric cycle was added into the watch with option of electric mobility to the wrist by electrodes as a part of the base of the watch. This cycle can be programmed to send the pulse to the wrist when it activated by On and will be stopped automatically after 30 minutes
The cycle has to send the pulse in  different frequencies from 1-43 Hz and this cycle shall be connected to the battery of the watch and should send electricity to the wrist in chosen frequency.

Clarification : electrical signals are transmitted from the body to the brain like any signals , such as pain signals or any out side effects .
Scientifically; Electric signals are similar to pain travel throughout the body back to the spinal cord. Their pathways look like a tree, where the spinal cord is the main trunk with branches extending out into the body, and twigs and side shoots spreading again so all tissues are reached. the various nerves enter the spinal column.
Our wristband transmits electric pulse to the arm witch supposed to be transmitted to the brain , however it  is known that this electric pulse will not arrive in the same power, and it is not affect the purpose of the device.
The main thing is to transmit the frequency and not the power of the electric pulse , so even the electric pulse power should be lower when it reach the brain , the frequency will stay the same (stable). And the brain will manage accordingly. It synchronizes the transmitted frequency ….
To approve the claim we have conducted scientific experiment, as follow:
Frequency test:
The experiment process:
The volunteer was asked to relax in a reclining chair.
Tow electrodes of frequency band transmitter (magic Alfa band),
and tow electric wires electrodes were attached to the volunteer fingers. All together created closed electrical cycle with the body.
The electric wire were attached to four different part of the body, four times: once at the scalp, and once at the heart area , once at arm and once at foot…
The experiment was carried out by a dedicated oscillator that activated by electrical low voltage of 4V and measures the transmitted frequency.
The environmental frequency of the oscillator was 50Hz.
The frequency transmitter was activated and transmitted  to the fingers 23 Hz.
The volunteer was asked to close his eyes, relax, and be still.
Once the recording begins, you will need to remain still throughout the test. The healthcare provider monitored The volunteer to observe any movements that can cause an inaccurate reading, such as swallowing or blinking.

Results: even the frequency band transmitter was attached only on fingers, every region of the body receives the same frequency, both in the head and the heart area both in hand and foot.
The environmental frequency was 50Hz and the body received a frequency of 23Hz..
The results show that each region of the body receives the same frequency of the recieved signal from the fingers (in our case 23hz – high beta wave).
Control: for controlling the results we have measured the frequency of the other side of the wires electrodes on air and without attaching the body,  (while the frequency band transmitter was attached only on fingers,),and got different result of  41 Hz and not  23 Hz as repeated at the different parts of the body.

Conclusion: This control result teaches that transmitted frequency was affected by  The environmental frequency of the oscillator, which was 50Hz as mentioned above. And teaches also that our nerve system in different parts of the body synchronizes the received electrical frequency at the same time of transmission , and produces the same frequency in the receiver part.
 The test was repeated five times with different volunteers and the same results were repeated.

EEG experiment on a healthy Volunteer

Age 35
Materials:
Devices: 1-  Emotiv Epoc+ device,  2- Alfa Headband,  3- Alfa Wristband
First Volunteer MM – Two days experiment:
 Day one- EEG measurement was done on the first Volunteer (MM) by using the wave reader EEG Emotiv device integrated with Mat lab program to check the brain electrical power and waves before and after using the Alfa Headband.
Day two-  EEG measurement was done on the first Volunteer (MM) by using the wave reader EEG Emotiv device integrated with Mat lab program to check the brain electrical power and waves before and after using the Alfa Wristband.
Goal: Efficacy on brain wave on the same Volunteer – Comparison between Headband and Wristband of Alfa. To check if the headband and the wristband cause the similar effect on brainwaves.
Each Volunteer was checked using the headband at the first day and was checked again 24 hours later using the wristband. (it was done one day later to avoid the effect of the headband at the first day)
EEG test was done for three minutes before using the band.
EEG test was done for 15 minutes after using the band.
Frequency of the Headband and the Wristband was 9 Hz
 Four graphs were documented showing the power of  frequencies: 3, 9, 13, 23 before using each band.
Four graphs were documented showing the power of  frequencies: 3, 9, 13, 23 after using each band
Process:
The volunteer was asked to relax in a chair.
14 electrodes were attached to the volunteer scalp.
The volunteer was asked to close his eyes, relax, and be still.
Once the recording begins, the volunteer will need to remain still throughout the test. The healthcare provider monitored the volunteer to observe any movements that can cause an inaccurate reading, such as swallowing or blinking.
EEG results of Volunteer (MM)  before and after using the headband

Beforenbm_eeg_graph01
Afternbm_eg_graph02

Beforenbm_eeg_graph03

​Afternbm_eeg_graph04

Beforenbm_eeg_graph05
Afternbm_eeg_graph06
Beforenbm_eeg_graph07

Afternbm_eeg_graph08

EEG results of Volunteer (MM)  before and after using the wristband

Beforenbm_eeg_graph09

Afternbm_eeg_graph010

Beforenbm_eeg_graph011

Afternbm_eeg_graph012

Beforenbm_eeg_graph013

Afternbm_eeg_graph014

Beforenbm_eeg_graph015

Afternbm_eeg_graph016

Conclusion :  the results show that Both wristband and Headband were effective in changing brain wave state. And both cause to similar changes.

Studies on Insomnia and Migraine (Headache)

1- Clinical Investigation- Insomnia

Double blinded- randomized study (two groups of subjects)
Selection of volunteers and clinical protocol:
Volunteers (n=21, ages: 28-64, Gender: M/F) were selected on the basis of routine visits to Biomed center clinic in Galilee and they were motivated to use Alfa rhythm device therapy for Insomnia. After a thorough explanation of Anti Sleepless components, they were asked to continue their daily activities and habits unchanged, and to use the device one time half an hour before sleeping time, or placebo device at evening. All usual medications for other illness were kept unchanged during the study period of three month.  An informed consent was obtained from each subject who was given a free-of-charge a device Anti sleepless or placebo.
At baseline, the sleeping time was documented for every subject. The next visit was scheduled for the coming one month and they were asked to prepare a daily report of time sleeping the only measure of subject compliance with the protocol. The last two visits sleeping time was documented and careful investigations of wellbeing and of any adverse effect were undertaken.

Results:
Eleven subjects (on treatment arm) reported in the second visit after one month that they started to feel better and sleep better after the first week, and instead of staying one hour on bed before sleeping, they reported that the stayed in average 15 minutes, after 1 month they reported that instead of three hours sleeping per night in average, they started to sleep between 5 hours, and 5-6 hours at the end of second month and 6- 7+ hours at the last month.
Five subjects reported no effect (3 of them had placebo and 2 had anti sleepless device.
See tables below:

Subjects Age/Sex Time of sleeping before treatment/hours Time of sleeping (after one month) Time of sleeping (After two months) Time of sleeping (After three months)
64/m 3 5 5 6
33/f 4 5 5 5
45/f 4 5 6 7
35/m 4 4 4 4
52/f 3 5 6 7
55/m 5 5 5 5
28/m 4 5 7 8
39/f 4 6 7 8
55/m 4 4 4 4
48/m 4 7 8 8
41/f 4 4 4 4
61/m 3 6 7 7
46/f 3 5 6 7
54/f 4 6 7 8
47/m 3 5 6 7
59/m 4 6 7 8
48/f 4 5 5 6
33/f 4 4 4 5
51/m 4 4 4 5
63/f 4 4 5 6
29/m 4 5 6 6

2.  Migraines

We have worked also on migraine patients, we have documented usage with 13 severe and 6 medium patients most of them reported that they have improved from the first use of half an hour, on average of using the device in on month they have reduced migraine attacks from five times a month to once or twice a month. The medium migraine patients reported that they were significantly improved.
All volunteers were diagnosed by their own doctors before starting the study. The results of this study are based on individual reports of the patients themselves and measured by scale from 0-10, as 0 demonstrates the severest situation while 10 demonstrates the mildest. The study included 19 patients from age 21-56 years old. 13 of them were diagnosed as severe with more than five attacks per month  and 6 as medium with until three attacks per month.
Results    
13 patients have been treated with device daily. Of these patients 8 with severe migraine and 5 of medium migraine had apparently a significant improvement after treatment for a week. After 30 – 45 days of treatment further improvement was observed.

Patient No. Age/sex After 7 days After 20 days After 30 days After 45 days
1- severe 0-2 39/M 5 7 8 10
2- severe 21/F 4 6 7 8
3- severe 25/M 6 8 10
4- severe 42/m 5 8 10
5- severe 47/m 4 7 9 10
6- severe 33/f 3 5 6 6
7- severe 29/f 6 8 10
8- severe 52/m 7 8 10
9- severe 56/f 5 7 9 9
10- severe 29/f 4 6 8 8
11- severe 24/m 3 4 6 7
12- severe 44/m 5 9 10
13- severe 47/f 8 10

 

1-medium 26/f 8 10
2-medium 24/m 7 9 10
3-medium 40/m 6 10
4-medium 27/M 5 7 9 10
5-medium 42/m 9 10
6-medium 47/m 7 7 7 7

New results until January 2018

Patient No. Age/sex After 7 days After 20 days After 30 days After 45 days
1- severe 0-2 50/M 4 6 7 7
2- medium 32/F 6 8 10
3- severe 35/M 5 8 9
4- severe 42/m 4 8 8
5- medium 44/m 6 7 9 10