This is a research study to evaluate a new non-invasive drug-free acute treatment of
headache in adolescents aged 12-17 years old. Participants are being asked to take part
in this study because they suffer from persistent headaches.
Device description:
The device is a wireless wearable battery-operated stimulation unit controlled by a
dedicated smartphone application. Treatments with Nerivio™ are self-administered by the
user at the onset of a headache. The Nerivio™ includes several main components:
A pair of electrodes covered with hydrogel and a removeable protective film
An electronic circuitry and a battery
A software that includes firmware and a software application for mobile platforms
An armband to secure the attachment of the device and enable a discreet treatment
Procedures and duration of participation
Participants will receive a device and will be asked to treat headaches with it and
report in the app the characteristics of the attacks at the beginning of the attack as
well as at 2 hours after the treatment. The study includes 3 visits to the clinic. The
investigators expect that participants will be in this research study for 8 weeks.
Why is this research study being done?
Participants are being asked to be in the study because they suffer from persistent
headaches.
The Nerivio device is approved by the FDA for acute treatment of migraine with or without
aura in patients 12 years of age or older. The purpose of this study is to assess the
effect of the Nerivio device for treating New Daily persistent Headache (NDPH) in
children. The Nerivio is a non-invasive device operated via a smartphone application that
changes brain activity. The device is worn on the upper arm, and the treatment is
self-administered at the headache onset. The device delivers non-painful electrical
pulses to the skin that stimulate the body to initiate a pain inhibition mechanism in the
brain. During the treatment, the users can adjust the intensity of the pulses according
to how they tolerate it.
Marc DiSabella is the person responsible for this research study at Children's National.
He is called the Principal Investigator.
What will happen in this research study?
Each participant will receive a device to be used at home for the acute treatment of
their headaches. The device produces electrostimulation parameters aimed to relief
headache pain. In addition, an app will be installed on the participants smartphone to
control the device and record their headaches and their feedback regarding the effect of
the device on their headaches.
Schedule of What the participants will do:
Enrollment Visit 1 (Day 0)
Arrive to Children's National Medical Center with one of their parents, for their
scheduled appointment. Bring packages of any medications that they are taking (for
any medical condition).
Eligibility assessment
Meet with Dr. DiSabella or one of the colleagues and/or the study team to answer
questions about their general health and their headaches.
If this form is received today, the participant and their parent(s) can take time to
read it carefully and make sure all of their questions and concerns are answered.
The participant may request another appointment in case they would like to read this
form at home and consult with family members or friends.
If the participant is a girl and have had their first period, they will provide a
urine sample for a pregnancy test.
If the participant agree to participate, a member of the study staff will install
the app on their smartphone. The investigators will provide an explanation on how to
operate the smartphone application.
the investigators will train the participant on how to complete their headache
diary.
Run-in phase (Days 1-28)
Device training Visit (Day 29-37)
Eligibility to continue in the study will be assessed based on their reports and
compliance in the run-in phase.
The participant will receive a device.
The investigator will train the participant how to use the device and find the
intensity level that is best for them
The participant can ask us any questions.
The participant will take the Nerivio home with them.
Treatment phase Day 1-28 following visit 2
Always have the device and their smartphone available.
Use the device for the treatment of their headache onset (and always with 60 minutes
of onset) and avoid taking rescue medication from the time of symptoms onset until 2
hours from treatment start (≈75 minutes from the end of the treatment). Report the
2-hour post treatment feedback through the smartphone application
The application will ask the participant to rate their headache pain level at the
beginning of the treatment, after 2 hours, and after 24 hours post treatment on a
scale of 0-3 (0= no pain; 1= mild; 2= moderate; 3= severe)
Call the study team if there is any change in their medical condition.
At the end of this phase, the participant will be contacted by a member of the study
team to schedule their next visit.
End of study visit 3. Please arrive to Children's National Medical Center for their
scheduled appointment, complete the study questionnaires, if required and return the
device.
