Treating epilepsy using X-System

Handbook for patients/caregivers during the trial

Thank you for joining our trial for improving epilepsy care in patients with hard-to-treat epilepsies.
The trial will involve
an icon representing a caregiver or parent caregiver
patient
doctor

The trial lasts for seven weeks, from the date of the first EEG in the hospital, to the last saliva sample

Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Weeks 1 - 2 — before treatment
Weeks 3 - 5 — during treatment
Weeks 6 - 7 — after treatment
Saliva Sample
with music
EEG in the hospital
!

Please do not play the music at home until after the second EEG (the night at the hospital listening to music) and then for the next 20 nights at home. After the third EEG, please do not play the music again at night until after the trial has finished.

You are welcome to resume listening to the music at night after the last saliva sample has been taken.

Using brain waves and music to help manage epilepsy

During the first EEG, we record the patient’s brainwaves as they sleep, which we then use to create a personalized playlist of music.
The music and playlist order is specifically designed to suppress or reduce epileptic activity which can affect quality of sleep, and to help the patient sleep more soundly.
The patient listens to music at night, at low volumes, while they sleep.
This trial includes 3 all-night EEG scans at the hospital; your doctor will consult with you about the dates for those.

How to take part in the trial

In order to help us to make our treatment as effective as possible, our trial involves the following steps:
1
Go to your hospital for three separate all-night EEG recordings (dates to be agreed with your doctor)
2
Play music every night for twenty nights at home
3
Collect nine saliva samples at specified times throughout the trial and write patient name, date and time on the label
4
Answer specially designed patient questionnaires before and after treatment
5
Fill in a daily seizure diary
6
Make sure the patient wears the Embrace Epilepsy Monitor Watch during the trial
7
Confirm/register the alerts on the Alert app once a day
!
Please note, although the function of the daily seizure diary and the Alert app on the Embrace are the same - to record seizures - we ask you to take care to fill out both, so that we don’t miss any seizures, or mark any false alarms as seizures in our trial data.
Instructions

Equipment List

You should have:
1
9 × Red-top tubes for saliva samples
2
1 × Notebook to use as a seizure diary
3
1 × Embrace epilepsy monitor
4
1 × Android telephone with the Alert app installed
5
1 × Boombox
6
1 × USB Pen Drive with music files for treatment
7
1 × Dual USB charging adapter

What should I do at the end of the trial?

At the end of the trial, please return the following to your doctor:
1
Android phone (in the box with all cables)
2
Embrace epilepsy monitor (in the box with charger and cable)
3
Saliva samples (keep them in a coolbox during transport to the hospital)
4
Seizure diary notebook
!

Previous patients have found the treatment so helpful in managing epilepsy that they continue to use the music at night long after the trial has finished.

We are therefore happy for you to keep the music equipment (speakers, MP3 player, USB charging adapter) after the end of the trial