CLINICAL EXPERIENCE: Generation 1 devices

1- 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. After an explanation of the device and signing of an informed consent form, they were asked to continue their daily activities and habits unchanged and to use the device for half an hour before sleep time. Half of the patients received a placebo device. All usual medications for other illness were kept unchanged during the study period of three month.
At baseline, the sleep 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 to fall asleep and sleeping length. For the last two visits time to fall asleep, and sleep time were documented and careful investigations of wellbeing and of 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 on 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.
Six subjects reported no effect (4 of them had placebo and 2 had used the operating device). The other 5 patients that had Sham devices, reported about minor enhancement.
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) Sham
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 documented usage with 19 patients (13 severe and 6 medium). Most of the patients reported that that they have improved following a month of treatment (30 minutes daily) from having reduced migraine attacks five times a month to once or twice a month.
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 severe situation while 10 demonstrates the mild. 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 up to three attacks per month. Following the pilot study additional patient were treated with similar results. The results summary are provided below:

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

3- ADHD

We had 23 patients that have used the device, and 19 of them have stopped taking Ritalin after one week of treatment, parents were reported that they feel better, and became more calm and concentrated at the end of the first month of treatment.
The results are based only on parents report , a formal study will be conducted in the future.
4.  Epilepsy

Animal Evidence
An evaluation study of the device was carried out by Pharmaseed Israel Ltd. The study evaluated the device protection in pilocarpine induced rat model of epilepsy.

Male/10/3 months Sprague Dawley (SD) rats provided by Harlan laboratories, Israel were used in this study. The average body weight was 332.9 g at study initiation in the two study groups (on Day 1). The minimal and maximal weight recorded in each group was within the range of ± 20 % of the group mean.

The pilocarpine model of epilepsy in rats was applied in order to evaluate the Test Device protection potential against temporal lobe pilocarpine-induced seizures.

Stimulation by the tested device decreased the duration of the seizures on all study days mostly for the more severe seizures (Stages 3 and 4 on Racine scale). Since the seizures develop with time after pilocarpine exposure, the most pronounced effect was recorded on Day 2.

Conclusion of the rat study: Stimulation by the tested device indicated a possible therapeutic potential of the device for the treatment of epilepsy.

Clinical Case Study Evidence
Case study is running for 5 months ago with a female patient 15 years old. She was treated twice daily for half an hour each treatment. Parents reported that she used to have epileptic seizures minimum four times a week and after using the device for three months she had only one attack in the first week, and for three months she was without any seizure attack.
After three months the parents stopped the treatment for two weeks and then the child had another attack.
So they were instructed to continue on daily base at least one time per day  . until May 2018 the parents have reported that no seizures attacks. ( 5 months no attacks)

5. Parkinson

Preliminary tests with the device showed improved symptoms in 10 patients (out of 10 patients). Motor symptoms improved in the Parkinson patients who were asked to perform a task before  and after brain stimulation. The task was holding a glass of water and watching tremors (we have some videos).

The results showed improvement in the task, and motor symptoms improved as well. The 10 patients were tracked for 3 weeks and had multiple stimulations, not only did motor symptoms improve, but their quality of life improved as well. When their symptoms were more controlled, the patients were more relax and active. 8 of them have been totally improved with no motor symptoms.

A pilot study in Romania carried out by two neurologists. As of  May 2018  we had partial report of the first three Parkinson patients (after using the device for 8 weeks), the results showed improvement in all parameters of the study (Tremor, Gait, Rigidity and Fatigue)

6. Hypertension

37 hyper tension patients used the device and 81% of them reported their blood pressure was balanced within the first month of usage,
All patients used the device 10-30 minutes twice daily. However 16 patients reported that they have used the device only once a day after two weeks of usage.
30 patients have reached normal level of BP within the first month. 3 patients have No change. 4 patients Minor change

The study is still running and additional data will be provided later.

Patients/G and age average Before using One month after Comments
1- M/51 140-50/85-90 120-30/80-90 Normal
2-M/47 150-60/100 125-35/70-75 Normal
3-M/63 135-40/85 120-30/80-90 Normal
4-F/52 160-70/100 150-60/95-100 Minor change
5-M/55 140-50/80-90 140-50/80-90 No change
6-F/41 140-50/90-5 120-30/80-90 Normal
7-F/69 140-50/95-100 130-35/80-90 Normal
8-M/49 150-55/90-5 130-35/70-75 Normal
9-F/50 140-50/90-5 120-30/80-90 Normal
10-M/49 150-60/70-5 120-30/80-90 Normal
11-M/61 145-55/95-100 145-55/95-100 No change
12-M/72 140-50/80-5 120-30/80-85 Normal
13-F/48 140-50/90-100 120-30/80-90 Normal
14- M/62 140-50/75-80 120-30/70-80 Normal
15-F/49 140-50/80-5 120-30/80-85 Normal
16- M/56 150-55/90-5 120-30/80-90 Normal
17-F/44 140-50/75-80 130-35/70-75 Normal
18-F/61 140-50/90-100 140-50/85-90 Minor change
19- M/44 140-50/80-5 140-50/80-5 No change
20-F/56 150-55/90-5 140-50/80-5 Minor change
21- M/54 150-60/70-5 130-35/70-75 Normal
22-F/33 140-50/80-5 125-35/70-75 Normal
23-M/47 140-50/90-100 120-30/80-90 Normal
24-M/59 140-50/75-80 120-30/80-90 Normal
25-F/67 150-55/90-5 130-35/70-75 Normal
26-M/63 150-155/90-5 120-30/80-90 Normal
27-M/58 140-50/80-5 130-35/70-75 Normal
28-F/53 150-60/70-5 130-35/70-75 Normal
29-F/46 135-40/85-90 130-35/70-75 Normal
30-M/39 140-50/90-100 120-30/80-90 Normal
31-M/49 150-60/80-5 120-30/80-90 Normal
32-F/40 150-155/90-5 130-35/80-85 Normal
33- M/70 135-40/85-90 130-35/70-75 Normal
34-M/55 150-60/80-5 120-30/80-90 Normal
35—F/50 135-40/85-90 120-30/80-90 Normal
36-F/38 150-60/90-100 140-50/85-90 Minor change
37- M/52 150-60/80-5 120-30/80-90 Normal