New Daily Persistent Headache (NDPH)NCT05310227
Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)
A study testing Nerivio in people with New Daily Persistent Headache (NDPH), run by Children's National Research Institute at 1 site in United States.
Trial summary
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- New Daily Persistent Headache (NDPH)
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 11 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants age 12-17 years old at the time of informed consent, inclusive.
- Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
- Participants who are on stable dosing of prophylaxis agents for at least three months.
- Participants have personal access to a smartphone (24/7)
- Participants must be able and willing to comply with the protocol
- Parents/Guardians must be able and willing to provide written informed consent
- Participants must be able and willing to provide informed assent
Who cannot join
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with epilepsy.
- Participants who have undergone nerve block (occipital or other) in the head or neck, or treatment with onabotulinum toxin A (Botox) to the head and/or neck in the prior four months.
- Current participation in any other clinical interventional study
- Participants without basic cognitive and motor skills required for operating a smartphone.
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- Pregnant or breastfeeding females
- Participants who have previous experience with the device
- Participants with arm circumference below 7.9 inches (20 cm)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Prospective, Single Arm, Open Label Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of New Daily Headache Persistence (NDHP) in Adolescents
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivio™ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects
Read the detailed description
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)
- Complete the diary whenever the participant experience a new headache.
- The study staff will contact the participant to schedule their next visit
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.
- Conditions
- New Daily Persistent Headache (NDPH)
- Being tested
- Nerivio
- Keywords
- New Daily Persistent Headache (NDPH), Nerivio Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief at 2 hours post-treatment
The proportion of participants achieving pain relief at 2 hours post-treatment in the test treatment, with no use of rescue/abortive medication (Pain relief defined as a change from severe to moderate, mild or none, moderate to mild or none, or mild to none)
Measured: 2 hours post-treatment
Within-patient consistency
The repeatability of headache change, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks
Measured: Before and at 1 Month after initiation of treatment with REN
Disappearance of associated symptoms at 2 hours post-treatment
Disappearance of nausea, photophobia and phonophobia at 2 hours post- treatment
Measured: 2 hours post-treatment
Functional disability at 2 hours post-treatment
The proportion of participants achieving a change of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication
Measured: 2 hours post-treatment
Improve of quality of life assessed by PedsMIDAS questionnaire
Change in average headache disability as measured by PedsMIDAS before and at 1 month after initiation of treatment with REN.
Measured: Before and at 1 Month after initiation of treatment with REN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Feb 2022
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Why it stopped: The device became FDA approved during enrollment thereby nullifying the need to complete the trial. No clinical data was collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Daily Persistent Headache (NDPH)Studies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Theranica
- Responsible party
- Principal investigator, Marc DiSabella, Children's National Research Institute
- Investigators
- Marc DiSabella, DO, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310227
- Sponsor's protocol ID
- Pro00016835
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of New Daily Headache Persistence (NDHP) in Adolescents
- ClinicalTrials.gov ID
- NCT05310227
- Acronym / sponsor ID
- Pro00016835
- Conditions
- New Daily Persistent Headache (NDPH)
- Keywords
- New Daily Persistent Headache (NDPH), Nerivio Device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device became FDA approved during enrollment thereby nullifying the need to complete the trial. No clinical data was collected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Theranica
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivio™ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects
Detailed description
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)
- Complete the diary whenever the participant experience a new headache.
- The study staff will contact the participant to schedule their next visit
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: NerivioParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participants age 12-17 years old at the time of informed consent, inclusive.
- Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
- Participants who are on stable dosing of prophylaxis agents for at least three months.
- Participants have personal access to a smartphone (24/7)
- Participants must be able and willing to comply with the protocol
Key exclusion criteria (9 listed)
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with epilepsy.
- Participants who have undergone nerve block (occipital or other) in the head or neck, or treatment with onabotulinum toxin A (Botox) to the head and/or neck in the prior four months.
- Current participation in any other clinical interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NerivioThe 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 | Device | Treatment |
Primary outcome
Pain relief at 2 hours post-treatment
Time frame: 2 hours post-treatment
The proportion of participants achieving pain relief at 2 hours post-treatment in the test treatment, with no use of rescue/abortive medication (Pain relief defined as a change from severe to moderate, mild or none, moderate to mild or none, or mild to none)
Within-patient consistency
Time frame: Before and at 1 Month after initiation of treatment with REN
The repeatability of headache change, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks
Disappearance of associated symptoms at 2 hours post-treatment
Time frame: 2 hours post-treatment
Disappearance of nausea, photophobia and phonophobia at 2 hours post- treatment
Functional disability at 2 hours post-treatment
Time frame: 2 hours post-treatment
The proportion of participants achieving a change of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication
Improve of quality of life assessed by PedsMIDAS questionnaire
Time frame: Before and at 1 Month after initiation of treatment with REN
Change in average headache disability as measured by PedsMIDAS before and at 1 month after initiation of treatment with REN.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc DiSabella, DO principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerivio in people with New Daily Persistent Headache (NDPH), run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief at 2 hours post-treatment (time frame: 2 hours post-treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.